Study of Efficacy of Bowel Preparation Before Colonoscopy

C.B. Fleet Company, Inc.3 sites in 1 country148 target enrollmentSeptember 2008

Overview

Phase: Phase 2
Intervention: FM-602
Conditions: Bowel Cleansing Prior to Colonoscopy
Sponsor: C.B. Fleet Company, Inc.
Enrollment: 148
Locations: 3
Primary Endpoint: Effectiveness of bowel cleansing assessed by the examining physician
Status: Completed
Last Updated: 14 years ago

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

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

December 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

C.B. Fleet Company, Inc.

Responsible Party

Sponsor

•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.

•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,