BLI-800-302: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

Launched by BRAINTREE LABORATORIES · Jul 18, 2007

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• -Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:
• • Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening
• • 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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse)
• • 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 with impaired consciousness that predisposes them to pulmonary aspiration.
• • Subjects who are undergoing colonoscopy for foreign body removal and decompression.
• • Subjects with clinically significant electrolyte abnormalities based on Visit 1 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 history of renal or hepatic insufficiency or congestive heart failure.
• • Subjects who had previous gastrointestinal surgeries
• • Subjects who are pregnant or lactating, or intending to become pregnant during the study.
• • Subjects of childbearing potential who refuse a pregnancy test.
• • Subjects who are 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 clinical, surgical, drug, or device study within the past 30 days.