Clinical trial NCT00503607: BLI-800-301: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Official title: A Safety and Efficacy Evaluation of BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Keywords: colonoscopy
bowel preparation
prep
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2007-07-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.


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.

Primary outcomes:
measure: Efficacy - preparation quality using a 4 point scale
timeFrame: 2-Day
Secondary outcomes:
measure: Safety - preparation related side effects; laboratory analysis
timeFrame: 30-Day
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Washington
country: United States
state: District of Columbia
city: Jupiter
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Monroe
country: United States
state: Louisiana
city: Laurel
country: United States
state: Maryland
city: Great Neck
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Lancaster
country: United States
state: Pennsylvania
city: Chesapeake
country: United States
state: Virginia
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John D McGowan, BS
role: STUDY_DIRECTOR
References: