Status:
COMPLETED
Study of Efficacy of Bowel Preparation Before Colonoscopy
Lead Sponsor:
C.B. Fleet Company, Inc.
Conditions:
Bowel Cleansing Prior to Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness of FM-602 as a bowel preparation before colonoscopy.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00771485
Start Date
September 1 2008
End Date
December 1 2008
Last Update
February 10 2012
Active Locations (3)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States, 28304
3
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320