Clinical trial NCT03342157
Conditions: Diabetic Gastroparesis
Sponsor: Wake Forest University Health Sciences
Start date: 2018-04-02; Completion date: 2018-08-17
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on the gut mucosa. These complex physiologic mechanisms appear may sufficiently promote stomach emp-tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this open label study, participants will be randomized into high and low dose groups to assess for ideal dosing and tolerability. It is the overall goal of this study to select the most promising dose-strength for the treatment of mild through severe gastroparesis.

Detailed description:

Arms: arm 1: 8.6/50 mg of senna/docusate, oral, twice daily arm 2: 8.6/50 mg of senna/docusate, oral, once daily
Interventions: intervention 1: senna/docusate
Intervention descriptions: intervention 1: Stimulant laxative

Protocol documents:
Prot_SAP_000.pdf: 
Protocol Version Tracking Date:  29 MAY 2018 
Page 1 of 7 
AURORA HEALTH CARE, INC. 
 
PROTOCOL TITLE:   Pilot study for the efficacy and tolerability of Senokot-S® 
in the treatment of diabetic gastroparesis 
 
 
 
 
 
 
 
 
PRINCIPAL INVESTIGATOR:  
Bradley Gose, MD 
 
 
 
 
 
 
Hospitalist 
 
 
 
 
 
 
2901 W Kinnickinnic River Parkway 
 
 
 
 
 
 
Suite 315 
 
 
 
 
 
 
Milwaukee, WI 53215 
 
 
 
 
 
 
Phone: (318)344-8668 
 
 
 
 
 
 
 
Fax: (414)385-2591 
 
 
 
 
 
 
 
 
Email: bwgose1@gmail.com 
 
 
 
 
INVESTIGATORS AND KEY PERSONNEL:   Gary Dennison, CIP 
 
 
 
 
 
 
                     Sheldon Garrison, PhD 
 
 
 
 
 
 
                     Maharaj Singh, PhD 
 
 
 
 
 
 
                     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT03342157


Protocol Version Tracking Date:  29 MAY 2018 
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This protocol was designed and developed by Aurora Healthcare, Inc. It is in-
tended to be used only in conjunction with institution-specific IRB approval for 
study entry. 
 
 
I.   
Background and Significance 
Diabetic gastroparesis can be a difficult-to-treat complication of longstanding diabetes that can 
significantly compromise quality of life in those affected. Today there is only one medication 
approved by the FDA for the indication of diabetic gastroparesis and it has received a black 
box warning due to potential for severe neurological side effects. There are other medications 
that have found some success in the treatment of diabetic gastroparesis, but they also have the 
potential for serious side effects, and some are only available through a special use program.1 
 
II.   Specific Aim 
The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the 
treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce peri-
stalsis, drive intra-luminal fluid and electrolyte shifts, and have an irritant effect on the gut mu-
cosa2,3. These complex physiologic mechanisms appear may sufficiently promote stomach emp-
tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this open label 
study, participants will be randomized into high and low dose groups to assess for ideal dosing 
and tolerability. It is the overall goal of this study to select the most promising dose-strength for 
the treatment of mild through severe gastroparesis.  
 
(c) 
Study End Points 
a. Primary Endpoint 
i. 
Modified GCSI-DD: Subjects will complete the modified Gastroparesis 
Cardinal Symptom Index-Daily Diary (mGCSI-DD)4,5. The mGCSI-DD is 
a validated patient reported outcome (PRO) instrument with excellent test-
retest reliability, and will be used as the primary instrument to assess for 
efficacy in this study. 
ii. Questions on the mGCSI-DD are a 6-point Likert scale from 0 (none) to 
very severe (5) that address: nausea, retching, vomiting, stomach fullness, 
ability to finish a normal-sized meal, feeling excessively full after meals, 
loss of appetite, bloating, external assessment of stomach size, upper ab-
dominal pain or discomfort. 
b. Secondary Endpoint 
i. 
Breakthrough medication use: Defined as the change in the frequency of 
use of breakthrough medication, which is the medication that has been 
previously prescribed on an as-needed basis to manage symptoms.  


Protocol Version Tracking Date:  29 MAY 2018 
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Any change in frequency of use of breakthrough medications will be used 
as a secondary endpoint to assess for efficacy in the study. 
ii. 
Bowel habits: Subjects will self report bowel habits during the baseline 
week and through the study period on the same questionnaire form.  Since 
Senokot-S functions primarily as a mild bowel stimulant any significant 
change in bowel habits will help to assess for tolerability in this study. 
IV.      Study Design 
The Phase II study design will be an open label, pre- and post-treatment assessment, prospec-
tive study. Sixty (60) study participants will be recruited over a 5-month period at a single site. 
Participants will be randomized into two treatment groups, a high- and low-dose, and will take 
medication dosed orally, twice daily or once daily at night.  
 
V.       Experimental Design, Methods, and Study Procedures 
a. Initial Identification of Potential Study Subjects Gastroenterologists who have 
agreed to refer their patient with diabetic gastroparesis for this study will make the ini-
tial contact with those patient (study inclusion/exclusion criteria will be provided to 
these physicians for ready reference). If the patient is interested in participating in the 
study the gastroenterologists will secure the patient’s verbal permission to provide their 
name and contact information (phone or e-mail) to Dr. Gose or another member of the 
study team. The study team member will contact the patient and arrange a time to meet 
with them to explain the study and to answer any questions the potential subject may 
have.   
 
b. Screening Visit The screening visit will include reviewing the participants’ complete 
medical history after reviewing and obtaining informed consent. Data from the partici-
pant’s medical history will be abstracted from the electronic medical record (EMR) and 
will be securely stored with other study-related data. Participants will be given the 
mGCSI-DD questionnaire and instructed on its use. At this visit participants will start 
recording their week of baseline scores by filling out a separate mGCSI-DD question-
naire and Breakthrough Medication Use and Bowel Habits documentation form daily. 
 
c. Visit 1 will occur 1 week after the screening visit. Participants will return with their 
mGCSI-DD baseline week of scores. They will be sequentially randomized (1:1) into 
either the high (8.6/50mg of senna/docusate taken by mouth twice daily) or low 
(8.6/50mg of senna/docusate taken by mouth once every night) dose study group. To 
reduce potential subject bias and placebo effect, participants will not be informed as to 
which dose of study medication they are randomized. They will be given their study 
medication and their 28-day mGCSI-DD questionnaire sheets, along with a pre-printed 
return envelope for use after completing their month of treatment in the study. They 
will be instructed to decrease use of any previously prescribed breakthrough medication 
as can safely be tolerated.  Examples of these medication may include prokinetics such 
as Reglan (metoclopramide), erythromycin, or domperidone; anti-emtics such as Zofran 
(ondansetron), or Compazine (prochloperazine); or analgesics such as tramadol, 


Protocol Version Tracking Date:  29 MAY 2018 
Page 4 of 7 
hydrocodone, or oxycodone.  They will also be instructed to resume any breakthrough 
medication use as previously prescribed at the completion of the study and to continue 
routine follow ups with their care providers.   
 
Subjects will be instructed to immediately contact the Principal Investigator if they ex-
perience episodes of significant diarrhea or rectal bleeding.  
 
Participants may be notified by phone at the end of their study period to verify data or 
request missing data. 
 
VI.  Risks 
Senokot-S side effects. Known side effects of Senokot-S include diarrhea, nausea or vomiting, 
stomach pain, rectal bleeding, gas, abdominal bloating, and potential for allergic reaction such 
as skin rash. There have been safety concerns in the past about potential complications from 
long term use of stimulant laxatives like Senokot-S, such as cathartic colon, increased inci-
dence of colorectal cancer, and liver disease.  Several recent studies and reviews refute those 
previous conclusions and suggest long-term use of mild stimulant laxatives is likely safe when 
needed3,6,7. Senokot-S is listed as pregnancy category C by the FDA.   
Women with child bearing potential will be required to use an effective form of birth control 
while participating in this study. 
 
Ineffective treatment of diabetic gastroparesis. Since this medication has not yet been studied 
in the treatment of diabetic gastroparesis it is possible that symptoms of the disorder may 
worsen.  The common symptoms of diabetic gastroparesis include nausea, vomiting, postpran-
dial fullness, early satiety, and abdominal pain.  
 
Loss of confidentiality. It is expected that this risk will be low because of numerous safeguards 
that will be in place, including standard data management procedures with Aurora Health Care. 
 
VII.  Benefits 
A successful outcome in the proposed study will have immediate implications by reducing the 
symptoms of diabetic gastroparesis. Such a result will address the significant unmet need by 
providing a safe, inexpensive pharmacological therapy for a difficult to treat chronic disorder. 
These findings would allow patients to reduce or eliminate intake of the only FDA-approved 
therapeutic medication, Reglan®, which has a black box warning and unfavorable side-effect 
profile. These known potential benefits are highly likely to outweigh the potential risks of the 
intervention in this study.    
 
VIII.  Study Population 
Inclusion Criteria: 
 Age 18-75 years, male and non-pregnant, non-lactating females 
 Diagnosis of type 1 or type 2 diabetes mellitus  
 Clinical diagnosis of diabetic gastroparesis 


Protocol Version Tracking Date:  29 MAY 2018 
Page 5 of 7 
 
Exclusion Criteria: 
 Diagnosed idiopathic gastroparesis 
 A history or inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis 
 A history of bowel obstruction, current unexplained abdominal pain, or undiagnosed 
rectal bleeding 
 Gastrointestinal cancer 
 Any active cancer 
 Prior gastric surgery 
 End-stage heart disease, liver disease, lung disease 
 Known or suspected drug abuse 
 Any condition requiring use of daily narcotics 
 Concurrent usage of mineral oil or products containing mineral oil 
 Current or recent (within the last 3 months) usage of Senokot-S, docusate or senna 
 
IX.  Recruitment and Screening 
Recruitment will occur through care provider referrals. Clinicians will be notified of the study 
through paper advertisement and posters. Initial screening will be done over the phone or 
through e-mail at the time of referral and will include a medical record review. Final screening 
and informed consent will be completed during the formal in person screening visit between 
the participant and research staff and is expected to take about one to two hours. 
 
X.  
Privacy Plan 
Patients will initially be notified of the potential to be in a research study by a current caregiv-
er. If the patient is agreeable to consideration for the study the research team will be contacted 
by phone or through e-mail by the clinician with the patient’s contact information. The patient 
will then be contacted by a member of the research team via an institution-based phone or 
EMR e-mail (based on the patient’s preference) for initial screening and to set up a clinic visit 
for final screening and informed consent.  
XI.     Data Collection 
The data to be collected will include a complete medical history of the participant, mGCSI-DD 
score forms, medication usage and bowel habits forms. Data will not be shared with any out-
side institutions. 
 
This research study plans to store and manage the subject lists, demographic information, vali-
dated questionnaire, study and breakthrough medication use, and bowel habits datasets in 
REDCap Cloud, a secure electronic data capture application that is based on Vanderbilt Uni-
versity’s REDCap application. Flexible for a variety of types of research, REDCap Cloud pro-
vides an intuitive data-entry interface for end users into study-specific data collection forms as-
sociated with study events. The application includes real time validation rules and query man-
agement, audit trails, and the automated export of study data into statistical programs. The 
REDCap Cloud platform is compliant with GCP predicate rule requirements and US FDA 21 


Protocol Version Tracking Date:  29 MAY 2018 
Page 6 of 7 
CFR Part 11 pertaining to the use of electronic records and signatures. Aurora Health Care, 
Inc. has executed an agreement for use of the application with nearly all research studies con-
ducted at Aurora. 
 
Access to data housed in REDCap Cloud and associated with this research study will be lim-
ited to those individuals listed on the IRB approved research study, as well as caregivers from 
Research Analytics for administrative reasons. Study team members access to the system and 
the data itself will be limited in accordance with need (i.e., biostatisticians may be limited to 
simply export the dataset to statistical tools, research coordinators may be limited to entering 
data, etc.). Overall, limiting access to study team members by need should reduce the risk of 
accidental disclosure and breach of confidentiality. However, using a cloud-based application 
may incidentally raise the risk of a breach in confidentiality, and, therefore, Aurora Health 
Care, Inc. has negotiated strong protections with the vendor in the event of a breach of confi-
dentiality. 
 
XII.  Statistical Plan 
All category and continuous variables will be described using appropriate descriptive statistics 
such as frequency, percentage for category variables and mean, standard deviation, median, 
and range for continuous variables. Pre and post outcomes variables for two groups of patients 
in the experimental groups will be compared using appropriate parametric and/or non paramet-
ric statistical tests. For all statistical tests an alpha level of 0.05 will be used and all statistical 
analysis will be carried out using SAS version 9.4, SAS Institute, Cary, NC. 
 
XIII. Monitoring Plan 
Data monitoring, safety monitoring, and statistical analysis will be done through the research 
office and principal investigator.  
Participants can stop the study at any time for any reason and can resume previous treatments 
whenever needed. Stopping points will be at the end of the 5 month study period or if a nega-
tive trend in mGCSI-DD post-treatment scores is observed. 
XIV. Regulatory Requirements 
The investigators and all key personnel agree to abide by the determinations of the Aurora IRB, 
including obtaining documented informed consent prior to inclusion of any individual in this 
research study. The investigators and all key personnel will comply with reporting require-
ments as outlined in the Aurora IRB Standard Operating Procedures (SOPs). In addition, inves-
tigators will permit access for on-site monitoring by representatives of the Aurora IRB, the Au-
rora Research Institute Investigator-Initiated Research unit, and the Aurora Research Institute 
Quality Improvement Program. 
 
 


Protocol Version Tracking Date:  29 MAY 2018 
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XV. References 
 
1 
Camilleri, M., Bharucha, A. E. & Farrugia, G. Epidemiology, mechanisms, and manage-
ment of diabetic gastroparesis. Clinical gastroenterology and hepatology : the official 
clinical practice journal of the American Gastroenterological Association 9, 5-12; quiz 
e17, doi:10.1016/j.cgh.2010.09.022 (2011). 
2 
Geboes, K., Spiessens, C., Nijs, G. & de Witte, P. Anthranoids and the mucosal immune 
system of the colon. Pharmacology 47 Suppl 1, 49-57 (1993). 
3 
Morales, M. A., Hernandez, D., Bustamante, S., Bachiller, I. & Rojas, A. Is senna laxa-
tive use associated to cathartic colon, genotoxicity, or carcinogenicity? Journal of toxi-
cology 2009, 287247, doi:10.1155/2009/287247 (2009). 
4 
Revicki, D. A. et al. Development and content validity of a gastroparesis cardinal symp-
tom index daily diary. Alimentary pharmacology & therapeutics 30, 670-680, 
doi:10.1111/j.1365-2036.2009.04078.x (2009). 
5 
Revicki, D. A. et al. Evaluating symptom outcomes in gastroparesis clinical trials: validi-
ty and responsiveness of the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-
DD). Neurogastroenterology and motility : the official journal of the European Gastroin-
testinal Motility Society 24, 456-463, e215-456, doi:10.1111/j.1365-2982.2012.01879.x 
(2012). 
6 
Muller-Lissner, S. A. Adverse effects of laxatives: fact and fiction. Pharmacology 47 
Suppl 1, 138-145 (1993). 
7 
Wald, A. Is chronic use of stimulant laxatives harmful to the colon? Journal of clinical 
gastroenterology 36, 386-389 (2003). 
 

ICF_001.pdf: 
 
 
For Medical Record Use 
 
Aurora IRB Stamp of Review 
Complete or apply a patient label 
Aurora IRB #:  
17-120 
 
 
Version date:  
10/23/2017 
 
Medical Record #  
 
 
 
 
 
INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE IN A RESEARCH STUDY 
 
(Consent – Research) 
Page 1 of 10 
 
 
 
 
Subject name:   
  Subject date of birth:  
 
 
Aurora Health Care, Inc. 
Consent to Participate in a Research Study 
 
Study Title 
Pilot study for the efficacy and tolerability of Senokot-S®  in the treatment of 
diabetic gastroparesis 
Study Investigator 
Bradley  Gose MD 
414-385-2590 
Sponsor 
Aurora Research Institute and the Aurora Foundation 
 
Why am I being asked to participate? 
You are being asked whether you would like to voluntarily participate in a research study about 
diabetic gastroparesis because you were identified by your health care provider as being affected with 
this disease and may benefit from this study. Diabetic gastroparesis, sometimes called delayed gastric 
emptying, is a condition that slows or stops the movement of food from the stomach to the small 
intestine. 
 
This form describes the study and what you would need to do. We will answer any questions you may 
have so that you can make an informed decision. 
 
What is a research study? 
A research study is an experiment, survey, or information collection whose purpose is to answer a 
specific question, such as:  
 
Does this work? 
 
Is it safe? 
 
What kind of treatment is better? 
 
How do people think or feel about this? 
 
To answer these questions, doctors and scientists need volunteers to participate in research studies. 
These volunteers are called “subjects.”  The doctors and scientists who run the research study are called 
“investigators.”  Other people who help them run the study are called the “research team.” 
 
Sometimes a drug or device being tested makes research subjects better, and sometimes it doesn’t. 
When you are a subject, the main purpose is to see if the study drug or device works and if it is safe. 
There may be side effects or risks to you, including some we don’t know about right now. 
 
This is a Phase 2 study. In a Phase 2 study, the drug is given to a larger group of people to see if it is 
effective and to further evaluate its safety. 
 
NCT03342157


 
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Version date:  
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INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE IN A RESEARCH STUDY 
 
(Consent – Research) 
Page 2 of 10 
 
 
 
A research study has specific rules the investigator must follow. The study rules may say that subjects 
can’t receive certain medications or treatments while they are in the study. We will explain the rules 
you will have to follow. If you can’t or don’t want to follow these rules, then you should not 
participate. 
 
What is the purpose of this study? 
In this study, we want to determine if the study medication, Senokot-S, helps to improve stomach 
emptying and symptoms in people who have diabetic gastroparesis. 
 
Senokot-S is approved by the U.S. Food and Drug Administration (FDA) as an over-the counter 
medication to treat occasional constipation. Senokot-S is not approved by the FDA to treat patients 
with diabetic gastroparesis, and its use in this research study is considered to be investigational. 
 
Who is sponsoring this study? 
The sponsor for this study is Aurora Research Institute.  
 
Where will this study take place? 
This study will take place at Aurora St Luke’s Medical Center. Dr. Gose will enroll a total of about 60 
subjects in this research study. 
 
What is involved? 
As a subject, you will be responsible for: 
 
attending all study visits 
 
taking the study medication as directed 
 
completing the provided questionnaires 
 
telling the investigator if you are feeling bad or worse than before 
 
telling the investigator if you have any changes in medications during the study 
 
following the directions of the investigator and research team 
 
If you agree to take part in this study, you will sign this consent form before any study-related 
procedures are performed. The investigator and research team will ask you questions and review your 
medical records to determine if you qualify to be in the study. 
 
The following questionnaires are for research purposes only. This means you will only complete these 
if you agree to be in the study: 
 
This is a modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) 
questionnaire. This is a questionnaire that asks how gastroparesis affects your daily life. It will 
take less than 10 minutes to complete each time you are asked to do so. 
 
Complete a questionnaire about the other medications you take for symptoms of gastroparesis 
and about your bowel habits. It will take you less than 5 minutes to answer this questionnaire 
each time you are asked to do so.  
 


 
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INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE IN A RESEARCH STUDY 
 
(Consent – Research) 
Page 3 of 10 
 
 
 
If you agree to take part in this study you will take the study medication, Senokot-S, for 28 days. You 
will be randomly assigned (like flipping a coin) to one of two study groups, one group will be given a 
higher dose of study medication, and the other group will receive a lower dose.. You will not be told 
what group you are randomized into. The study medication doses for both groups are within the 
current manufacturer’s dosing guidelines. 
 
Dr. Gose will tell you how much of the study medication you should take and answer any questions 
you have about taking the study medication. 
 
The chart below will explain what you will do at each study visit. 
 
What will happen at each study visit? 
 
Visit 
During this visit, you will 
How long is 
this visit? 
Reminders 
Visit 1 
(Screening) 
 Review and sign this consent form first 
 We will review your medical history 
 Determine if you qualify for the study 
 Provide you with the study 
questionnaires 
 
1-2 hours 
Bring a list of all 
medications you take 
including any over the 
counter medications 
Visit 2 (one 
week after Visit 
1) 
 Review your questionnaires to date 
 Assign you to a study group and provide 
you with your study medication 
 Provide you with your questionnaires 
for the remainder of the study 
1 hour 
Bring in your study 
questionnaires 
 
Dr Gose will talk to you about reducing any medication you currently take for gastroparesis as can 
safely be tolerated while you are taking the study medication. 
 
You are encouraged to call Dr. Gose at any time with health concerns related to study participation. 
Health concerns that may require immediate attention may include, but are not limited to, 
significant diarrhea and rectal bleeding.  
 
After you finish the 28 days of Senokot-S, you will use a pre-addressed, postage paid envelope to mail 
your study questionnaires back to Dr. Gose. After you return the study questionnaires, your active 
participation in this study will be ended. 
 
Dr. Gose will review the information you recorded on the study questionnaires. If any information is 
missing or he has questions about what you wrote, he may contact you to ask you follow up questions. 
Dr. Gose will contact you by telephone or e-mail, depending on which method is easier for you. 
 


 
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INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE IN A RESEARCH STUDY 
 
(Consent – Research) 
Page 4 of 10 
 
 
 
Are there any risks to me? 
There may be risks, side effects and discomforts if you choose to participate in this study. These can be 
physical, emotional, financial or social. The ones we know about are listed below. 
 
There may be side effects from the study drug Senokot-S. Many side effects go away, but sometimes 
they can be serious, long-lasting, or may never go away. There may be other side effects that we don’t 
know about yet, so be sure to tell the investigator about any unusual symptoms. 
 
Risks of Senokot-S 
 
Common 
Rare but serious (fewer than 1 in 100 people) 
 
Diarrhea 
 
Abdominal (stomach) cramps 
 
Flatulence (gas) 
 
Nausea 
 
Urine discoloration 
 
Difficulty breathing 
 
Severe abdominal pain 
 
Rash/hives 
 
Diminished bowel function with long term use 
 
Rectal bleeding 
 
You should not become pregnant while you are participating on this study. If you are a woman who 
can become pregnant, you should practice an effective method of birth control while you are taking the 
study medication, Senokot-S. Please talk to your primary care doctor if you have questions about what 
birth control method is right for you. If you become pregnant during the study you must tell Dr. Gose 
immediately. You will not be able to continue in the study if you become pregnant. 
 
Questionnaire risks: You will complete questionnaires in this study. Some the questions may make 
you feel uncomfortable, like discussing your bathroom habits. These questions are very important for 
the study. If you think you will be uncomfortable answering these questions you should talk to Dr. 
Gose before agreeing to be part of this study. 
 
Are there any benefits to me? 
You may or may not benefit from being in this study. Your gastroparesis symptoms could improve in 
the following ways: less nausea, less bloating (feeling full), less abdominal pain. 
 
It is also possible that your condition could stay the same or even get worse. We hope the information 
learned will help other patients with gastroparesis in the future. 
 
How much will it cost to participate? 
There will be no cost to you, or your insurance, if you agree to take part in this study. 
 
In this study, the sponsor will pay for: 
 
The study medication, Senokot-S 
 


 
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INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE IN A RESEARCH STUDY 
 
(Consent – Research) 
Page 5 of 10 
 
 
 
Will I be paid to participate? 
You will not be paid to participate in this study. 
 
How long will I be in the study? 
You will be in the study for 5 weeks. 
 
The study may be stopped early by the sponsor or the investigator. You could be asked to stop being in 
the study for any of the following reasons:  
 
for your safety 
 
if you do not follow our directions for this study 
 
if you become pregnant 
 
If you stop being in the study early for any reason, we will ask you to do the following: 
 
notify the investigator of your decision 
 
Do I have to be in this study? 
You do not have to be in this study. If you start the study, you may stop at any time. There is no 
penalty or loss of benefits if you don't want to participate, and your decision won't affect your regular 
medical care.  
 
You may decide to participate now, but change your mind and withdraw from the study anytime 
without penalty or loss of benefits. If you decide to withdraw before the last study visit, let the 
investigator know. There may be special procedures to follow for your safety. 
 
If you don’t want to be in this study, your other options include: 
  
Alternate treatment 
Potential risks 
Potential benefits 
Resume treatments 
previously prescribed to 
you by your physician 
including any diet 
recommendations or 
prescription medications 
Persistence of gastroparesis 
symptoms, or side effects of 
previously prescribed medications 
Relief of gastroparesis symptoms 
including less nausea/vomiting, 
abdominal bloating, or abdominal 
pain 
Reglan (metoclopramide) 
Involuntary muscle movements, 
seizures, and others as described 
in the medication’s information 
Relief of gastroparesis symptoms 
including nausea. 
 
This is not a complete list. Your doctor can tell you about all your options, and their risks and benefits. 
 
What if I am harmed from being in the study? 
If you get hurt or sick from being in this study, you should seek medical treatment as needed. Be sure 
to tell the investigator as soon as possible.  


 
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 
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Version date:  
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INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE IN A RESEARCH STUDY 
 
(Consent – Research) 
Page 6 of 10 
 
 
 
We will bill your insurance, if you have any, and you will have to pay your usual copays or 
deductibles. If you have Medicare, we may send information that identifies you to Medicare. If you do 
not have insurance or if your insurance does not cover your treatment, we will bill you for the costs of 
the treatment. 
 
Will my records be kept confidential? 
Your study records will be kept as confidential as possible. You can find out more in the section 
“Information about Confidentiality and HIPAA Authorization.” 
 
What if there is new information about this study? 
If we learn any new information about this study that might make you change your mind about 
participating, we will tell you. 
 
If you want to know the results of the study once it is over, you can ask the investigator. 
 
Who oversees this study? 
The Aurora Institutional Review Board (IRB) has approved this study. The IRB is a group of people 
who review all research studies at Aurora to check that they meet federal laws and ethical standards. 
 
IRB approval only means it is ok for the study to begin. Only you can decide if being in this study is the 
right decision. Feel free to talk about this study with your family, friends and personal doctor before 
you decide. 
 
Who do I contact? 
 
If … 
You should contact 
Contact information 
You are harmed by the research 
Bradley Gose MD 
or 
Aurora Patient-Centered Research 
414-385-2590 
or 
414-385-1873 
You have questions about your 
rights as a research subject 
Aurora IRB office 
414-219-7744 (outside 
Milwaukee: 877-219-7744) 
You have questions, problems, 
concerns, information, input or 
complaints about this research 
study 
Bradley Gose MD 
or 
Aurora IRB office 
414-385-2590 
or 
414-219-7744 (outside 
Milwaukee: 877-219-7744) 
 


 
 
For Medical Record Use 
 
Aurora IRB Stamp of Review 
Complete or apply a patient label 
Aurora IRB #:  
17-120 
 
 
Version date:  
10/23/2017 
 
Medical Record #  
 
 
 
 
 
INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE IN A RESEARCH STUDY 
 
(Consent – Research) 
Page 7 of 10 
 
 
 
Information about Confidentiality and HIPAA Authorization 
 
The Privacy Rule of the federal Health Insurance Portability & Accountability Act (HIPAA) is a law 
that protects the confidentiality of your personal health information. This Authorization describes your 
rights and explains how your health information will be used and disclosed. 
 
Why is access to my health information being requested? 
To help answer the research questions, the investigator and research team will use and store personal 
health information about you. We are asking your permission to use and share it with others, as 
explained below. If you don’t give this permission, you won’t be able to take part in the research study. 
 
What information will be collected and used? 
When you are a subject, we will collect health information about you that also includes your name, 
address, telephone number, or other data that could identify the health information as yours. Under 
HIPAA, this health information is protected and can’t be used without your permission, unless 
otherwise permitted by law. If you sign this authorization, you are giving permission for Aurora 
Health Care to use and disclose your personal health information as described below. 
 
The following are examples of personal health information that may be collected for this study: 
 
results of tests and procedures 
 
information about your medical conditions and history 
 
The collected information may contain your name, address, telephone number, health plan number, 
date of birth, medical record numbers, dates relating to various medical procedures, and/or other 
identifying information.  
 
Who will see my protected health information? 
By signing this Authorization, you allow the Aurora Research Institute research team to use your 
personal health information to carry out and evaluate this study. You also allow access to your 
personal health information (including direct access to your medical records at Aurora) to the 
following: 
Who may have access: 
Purpose: 
The sponsor of the study and anyone working on 
its behalf 
To oversee the study and make sure the 
information is correct 
Aurora consultants and employees, including IRB 
members 
To protect the rights and safety of subjects and 
make sure the study information is correct 
Organizations that regulate research (such as the 
FDA, Office for Human Research Protections 
(OHRP), or similar government agencies in the US 
and other countries) 
To make sure applicable laws are being followed 


 
 
For Medical Record Use 
 
Aurora IRB Stamp of Review 
Complete or apply a patient label 
Aurora IRB #:  
17-120 
 
 
Version date:  
10/23/2017 
 
Medical Record #  
 
 
 
 
 
INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE IN A RESEARCH STUDY 
 
(Consent – Research) 
Page 8 of 10 
 
 
 
Who may have access: 
Purpose: 
Organizations that grant accreditation to hospitals 
and research programs 
For Aurora to remain accredited 
 
Will you keep my health information confidential? 
We will keep your personal health information as confidential as possible. We will only share it as 
described above or if required or permitted by law. It is not likely your information will be given to 
others without your permission. However, once your information leaves Aurora, we can’t control how 
it is used, and it will no longer be covered by the HIPAA Privacy Rule. 
 
Will other people know that I was in this study? 
If the results of this study are published, your name or other personal information will not be included. 
 
How long will my personal health information be used? 
Access to your personal health information begins as soon as you sign this form. This authorization 
expires when the study if finished. 
 
What if I change my mind? 
If you don’t want us to use and disclose your personal health information anymore, you must let the 
investigator know in writing. If you need help with this, you can ask the research team or call the 
Aurora IRB office at 414-219-7744 (outside Milwaukee: 877-219-7744). 
 
If you withdraw permission for us to use your personal health information: 
 
you can’t continue in the research study 
 
we will stop collecting health information from you 
 
we will still use and disclose any information that we gathered while you were a subject 
 
there will not be any penalty or loss of benefits to which you are otherwise entitled 
 
Can I see my study records? 
You have the right to see and get a copy of your study records.  However, by signing this 
Authorization, you agree that you will not be able to see your study records during the research study.  
You can only see them once you complete the study or drop out. 
 


 
 
For Medical Record Use 
 
Aurora IRB Stamp of Review 
Complete or apply a patient label 
Aurora IRB #:  
17-120 
 
 
Version date:  
10/23/2017 
 
Medical Record #  
 
 
 
 
 
INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE IN A RESEARCH STUDY 
 
(Consent – Research) 
Page 9 of 10 
 
 
 
Form IC 701A 
Subject name:  
 
 
I have read this form and the research study has been explained to me. 
 
I have been given the chance to ask questions, and my questions have been answered. I have been told 
who to call if I have more questions. 
 
I agree to be in the research study described above. 
 
I will receive a copy of this consent form after I sign it. A copy will be put in my medical record and/or 
study record. 
 
I am not giving up any of my legal rights by signing this form.  
 
 
Subject signature 
Date 
Time 
 
 
Witness signature (if applicable*) 
Date  
Time 
*Use when the subject cannot read the consent (for example, subject is blind, illiterate, or does not speak English). The witness must be 
present for the entire consent discussion. The witness signature means that the information in this document was presented to the subject, 
and the subject appeared to understand it. 
 
 
For Site Use only: 
 
I have carefully explained to the subject the nature and purpose of this study. 
 
The subject has been given enough time and an adequate place to read and review this form. 
 
The subject has had a chance to ask questions and receive answers about this study. 
 
 
Name of person obtaining informed consent (print) 
Title 
Phone number 
 
 
Signature of person obtaining informed consent 
Date  
Time 
**Per state law, a physician investigator should conduct the risk/benefit/alternative discussion and complete the above signature if there is a 
medical intervention required of the research and a treatment consent would be required for that intervention.** 
 


 
 
For Medical Record Use 
 
Aurora IRB Stamp of Review 
Complete or apply a patient label 
Aurora IRB #:  
17-120 
 
 
Version date:  
10/23/2017 
 
Medical Record #  
 
 
 
 
 
INFORMED CONSENT / AUTHORIZATION TO PARTICIPATE IN A RESEARCH STUDY 
 
(Consent – Research) 
Page 10 of 10 
 
 
 
Form IC 701A 
Risk/Benefit/Alternatives Discussion 
I have explained and discussed with the subject or his/her legally authorized representative 
 
The nature of the research 
 
Potential risks and benefits 
 
The alternate treatments available to the subject and the benefits and risks of each 
 
 
Name of person providing this information (print) 
Title 
 
 
Signature of person providing this information 
Date 
 
 
 
DOCUMENTATION OF INFORMED CONSENT: 
 All elements of the study contained in this document were discussed with the subject. 
 The subject had the opportunity to ask questions, all questions were answered, and the subject 
expressed understanding. 
 The subject gave written informed consent before any research-related procedures began. 
 The subject received a copy of the signed and dated consent form. 
 
 
Signature of person obtaining informed consent 
Date 
 
 
 
 
 
 
 
 
 
 
THIS PAGE IS FOR DOCUMENTATION ONLY. IF GIVEN TO SUBJECTS, IT MAY BE BLANK. 
FILE A SIGNED COPY OF THIS FORM IN THE PATIENT’S MEDICAL RECORD (if applicable).  
Keep the original in the investigator’s research records. .  
Form IC 701A v. 4/10/17