Study of Efficacy of Bowel Preparation Before Colonoscopy

Phase 2

Completed

• Conditions: Bowel Cleansing Prior to Colonoscopy
• Interventions: Drug: FM-602; Drug: Marketed Bowel Cleanser

• Registration Number: NCT00771485
• Lead Sponsor: C.B. Fleet Company, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	FM-602	-
2	Marketed Bowel Cleanser	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of bowel cleansing assessed by the examining physician	During colonoscopy

Trial Locations

Locations (3)

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Gastroenterology Associates of Tidewater; 🇺🇸 Chesapeake, Virginia, United States

Cumberland Research Associates, LLC; 🇺🇸 Fayetteville, North Carolina, United States