BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Colonoscopy · Bowel Preparation · Endoscopy
Bottom Line
View on ClinicalTrials.gov: NCT01786629 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- SUPREP Bowel Prep Kit (Drug); FDA approved bowel preparation containing electrolytes (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Braintree Laboratories
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent") |
95; 86 | — |
Summary
Eligibility Criteria
Inclusion Criteria
Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
At least 18 years of age
If female, and of child-bearing potential, is using an acceptable form of birth control
Negative urine pregnancy test at screening, if applicable
In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Exclusion Criteria
Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
Subjects who had previous significant gastrointestinal surgeries
Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on screening laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
Subjects with a prior history of renal, liver or cardiac insufficiency
Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
Subjects undergoing colonoscopy for foreign body removal and/or decompression.
Subjects who are pregnant or lactating, or intending to become pregnant during the study.
Subjects of childbearing potential who refuse a pregnancy test.
Subjects allergic to any preparation components.
Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
Subjects who withdraw consent before completion of Visit 1 procedures.
Data sourced from ClinicalTrials.gov (NCT01786629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.