BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Completed · Phase 3
Conditions studied: Colonoscopy
In brief
To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.
Key facts
- Study ID
- NCT00856843
- Run by
- Braintree Laboratories
- People needed
- 136
- Starts
- 2009-02-01
- Last updated by the study team
- 2010-11-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
- At least 18 years of age
- Otherwise in good health, as determined by physical exam and medical history
- 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
You may not qualify if…
- Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
- Subjects who had previous gastrointestinal surgeries.
- Subjects with known or suspected electrolyte abnormalities such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
- Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
- Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects undergoing colonoscopy for foreign body removal and 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.
Where it is running
- University of South Alabama — Mobile, Alabama, United States
- Jupiter Research — Jupiter, Florida, United States
- Miami Research Associates — Miami, Florida, United States
- Indiana University Medical Center — Indianapolis, Indiana, United States
- Long Island GI Research Group — Great Neck, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.