BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
1 other identifier
interventional
386
1 country
12
Brief Summary
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedResults Posted
Study results publicly available
December 27, 2013
CompletedDecember 27, 2013
December 1, 2013
3 months
September 18, 2008
February 19, 2013
December 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy - Preparation Quality Using a 4 Point Scale
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent")
2 days
Secondary Outcomes (10)
Serum Chemistry Results (mEq/L)
2 days
Hematology Results (%)
2 days
Serum Chemistry Results (U/L)
2 days
Serum Chemistry Results (mg/dL)
2 days
Serum Chemistry Results (g/dL)
2 days
- +5 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALmulti-dose preparation for oral administration prior to colonoscopy
2
ACTIVE COMPARATORmulti-dose preparation for oral administration prior to colonoscopy
Interventions
multi-dose preparation for oral administration prior to colonoscopy
Eligibility Criteria
You may qualify if:
- Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:
- Evaluation of barium enema results
- GI bleeding
- Anemia of unknown etiology
- Neoplastic disease surveillance
- Abnormal 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, intra-uterine device, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).
- Negative urine pregnancy test at screening, if applicable.
- +1 more criteria
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 with impaired consciousness that predisposes them to pulmonary aspiration.
- Subjects who are undergoing colonoscopy for foreign body removal or decompression.
- Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
- Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass).
- 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 surgical, drug, or device study within the past 30 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Advanced Clinical Research Institute
Orange, California, 92869, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Gastrointestinal Associates
Jackson, Mississippi, 39202, United States
Options Health Research
Tulsa, Oklahoma, 74104, United States
Northwest Gastroenterology Clinic
Portland, Oregon, 97210, United States
Franklin Gastroenterology
Franklin, Tennessee, 37067, United States
Memphis Gastroenterology Group
Germantown, Tennessee, 38138, United States
The Frist Clinic
Nashville, Tennessee, 37203, United States
Houston Medical Research Associates
Houston, Texas, 77090, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Northwest Gastroenterology Associates
Bellevue, Washington, 98004, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- John McGowan, Director, Clinical Research
- Organization
- Braintree Laboratories, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 22, 2008
Study Start
August 1, 2008
Primary Completion
November 1, 2008
Last Updated
December 27, 2013
Results First Posted
December 27, 2013
Record last verified: 2013-12