Clinical trial NCT00771485: Study of Efficacy of Bowel Preparation Before Colonoscopy
Official title: Study of Efficacy of Bowel Preparation Before Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bowel Cleansing Prior to Colonoscopy
Lead sponsor: C.B. Fleet Company, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the effectiveness of FM-602 as a bowel preparation before colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Are men or nonpregnant women who are scheduled for an elective colonoscopy and who are at least 18 years of age,
* Are, in the opinion of the Investigator, able to communicate with study personnel and comply with the requirements of the study,
* Are able and willing to follow the study-specified testing including the diet and hydration regimen, and
* Have been informed of the nature and risks of the study and have given written informed consent at Screening and before any study-related tests are done.

Exclusion Criteria:

* Have any known contraindications to the study procedures or treatment,
* Have clinically significant active cardiovascular disease, including a history of myocardial infarction, within the past 6 months and/or heart failure
* Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus,
* Have any history of prior colon surgery,
* History of active inflammatory bowel disease,
* Have clinical evidence of dehydration,
* Are pregnant or breast-feeding,
* Are unwilling to abstain from alcohol consumption from the day before colonoscopy until discharged from the study,
* Are unwilling to use any prohibited medications, including laxatives, 4 days before receiving the first study dose,
* Have received any investigational agent within 30 days before dosing,
* Have any known or suspected allergies, sensitivity or an unwillingness to consume components of the study medication,
* Known or suspected phenylketonuria (PKU) or sensitivity to products containing phenylalanine, or is on a phenylalanine-reduced diet,
* A history of hemolysis or taking concomitant medications known to precipitate hemolytic reactions,
* Have any other condition which in the Investigator's opinion would make the subject unsuitable for inclusion into the study.

Primary outcomes:
measure: Effectiveness of bowel cleansing assessed by the examining physician
timeFrame: During colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
Study officials:
affiliation: C.B. Fleet Company, Inc.
name: Sherrie McNamara, RN, MSN, MBA
role: STUDY_DIRECTOR
References: