NCT00771485CompletedPhase 2
Study of Efficacy of Bowel Preparation Before Colonoscopy
C.B. Fleet Company, Inc.3 sites in 1 country148 target enrollmentStarted: September 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 148
- Locations
- 3
- Primary Endpoint
- Effectiveness of bowel cleansing assessed by the examining physician
Study Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of FM-602 as a bowel preparation before colonoscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
1
Experimental
Intervention: FM-602 (Drug)
2
Other
Intervention: Marketed Bowel Cleanser (Drug)
Outcomes
Primary Outcomes
Effectiveness of bowel cleansing assessed by the examining physician
Time Frame: During colonoscopy
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
Loading locations...
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