Efficacy Study of Bowel Preparation Before Colonoscopy

C.B. Fleet Company, Inc.2 sites in 1 country72 target enrollmentJanuary 2008

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Bowel Cleansing Prior to Colonoscopy
Sponsor: C.B. Fleet Company, Inc.
Enrollment: 72
Locations: 2
Primary Endpoint: Effectiveness of bowel cleansing based on a grading scale.
Status: Completed
Last Updated: 14 years ago

The purpose of this study is to determine the efficacious dose range when used as a bowel preparation before colonoscopy.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

April 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

C.B. Fleet Company, Inc.

Responsible Party

Sponsor

•Men and nonpregnant women who are scheduled for an elective colonoscopy and who are at least 50 years of age.
•Are able to communicate with study personnel and comply with study requirements.
•Are able and willing to follow study-specified testing, diet, and hydration regimen.
•Have been informed of the nature and risks of the study and have given written informed consent.

•Have known or suspected liver disease or any history of abnormal liver function tests.
•Have clinically active cardiovascular disease within the past 6 months.
•Have blood pressure greater than 150/90 mm Hg.
•Have known or suspected renal insufficiency.
•Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.
•Have a history of prior bowel surgery within 2 years before enrollment, or active inflammatory bowel disease.
•Have diabetes or a history of diabetes.
•Have clinical evidence of dehydration.
•Are pregnant or breast-feeding.
•Are unwilling to abstain from alcohol consumption from one day before colonoscopy until discharged from the study.