Clinical trial NCT01212445: Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
Official title: A Randomized, Open-Label, Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-09-30
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.

In addition, the proportion of subjects with a BM (without straining and without hard and/or lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E was evaluated for the time to first BM.


Eligibility criteria: Inclusion Criteria:

* A willingness to participate in the study and comply with its procedures
* Must be ambulatory
* Male or female subjects aged 18 years or older who met two or more of the following modified Rome III-based criteria for constipation: (a) straining during at least 25% of defecations; (b) lumpy or hard stools in at least 25% of defecations; (c) sensation of incomplete evacuation for at least 25% of defecation; (d) sensation of anorectal obstruction/blockage for at least 25% of defecations; (e) manual maneuvers to facilitate at least 25% of defecations (eg, digital evacuation, support of the pelvic floor), and (f) fewer than 3 defecations per week
* Criteria fulfilled for the last 3 months with symptom onset at least 6 mo prior to diagnosis
* Had a self reported or documented history of chronic constipation
* Agreed not to use laxatives other than the study treatment from baseline/informed consent to end-of-study
* Agreed to maintain a similar diet from the week before Visit 3 to the end-of-study were to be enrolled
* Additionally required not to use any treatment known to cause constipation during the study (for subjects enrolled after Amendment 1)
* If a female subject, either surgically sterile, 2 years postmenopausal, or using an acceptable method of contraception. Abstinence was not an acceptable method of contraception. Females of childbearing potential had to have a urine pregnancy test (human chorionic gonadotropin \[HCG\]) that was negative at Visit 3
* Be able to read and write in the diaries in English

Exclusion Criteria:

* Had loose stools without the use of laxatives
* Recurrent abdominal pain
* Known or suspected bowel perforation, obstruction, or fecal impaction; or had gastric retention, inflammatory bowel disease, bowel resection, or colostomy
* Celiac disease or known gluten sensitivity
* Known renal or hepatic insufficiency
* Recent history of alcohol abuse or drug abuse
* History of psychiatric disorders
* History of significant ongoing medical problems or scheduled for surgical procedures
* Subjects who, in the opinion of the Investigator, should not have been included in the study for any reason, including inability to follow study procedures
* Participated in an investigational clinical, surgical, drug or device study within the past 30 days
* Pregnant or lactating
* Allergic to PEG or PEG+E
* Employed by or have immediate family members employed by a company that manufactures laxative products
* Participant or family member of the Investigator or site staff directly involved with this study

Primary outcomes:
measure: Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration
timeFrame: From time of study drug treatment up to 24 hours
Secondary outcomes:
measure: Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration
timeFrame: From time of study drug administration up to 3 Days
measure: Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration
timeFrame: From time of study drug treatment up to 12 hours
measure: Mean Visual Analog Scale (VAS) Rating for BM Control
timeFrame: From time of study drug treatment up to 24 hours
measure: Mean VAS Rating for Gas
timeFrame: From time of study drug treatment up to 24 hours
measure: Mean VAS Rating for Bloating
timeFrame: From time of study drug treatment up to 24 hours
measure: Mean VAS Rating for Abdominal Discomfort/Cramping
timeFrame: From time of study drug treatment up to 24 hours
measure: Mean Participant Global Assessment of Treatment
timeFrame: From time of study drug administration up to 2 Days
Other outcomes:
Locations:
city: ORK
country: Ireland
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: