Phase 3
N=394
BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Colon Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00756977 ↗Enrolled (actual)
394
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Efficacy - Preparation Quality Using a 4 Point Scale — 90; 84 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BLI850 (Drug); polyethylene glycol 3350 based bowel preparation (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Braintree Laboratories
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy - Preparation Quality Using a 4 Point Scale |
90; 84 | — |
| SECONDARY Serum Chemistry Results (mg/dL) |
-3.08; -3.59; -0.08; -0.13; 0.00; 0.03 | — |
| SECONDARY Hematology Results (%) |
0.03; 0.07; 0.06; -0.09; 0.50; 0.38 | — |
| SECONDARY Serum Chemistry Results (U/L) |
1.46; 1.96; 0.93; 4.20; -11.1; -16.5 | — |
| SECONDARY Serum Chemistry Results (mEq/L) |
0.71; 0.53; -0.88; -0.51; 0.63; 0.27 | — |
| SECONDARY Serum Chemistry Results (g/dL) |
0.03; -0.00; 0.06; 0.01 | — |
| SECONDARY Serum Chemistry Results (GFR) |
-0.21; -2.82 | — |
| SECONDARY Hematology Results (1000/MCL) |
1.82; -1.09; -0.55; -0.59 | — |
| SECONDARY Hematology Results - Hemoglobin |
0.20; 0.20 | — |
| SECONDARY Hematology Results - Red Blood Cells |
0.07; 0.04 | — |
| SECONDARY Serum Chemistry Results (Osmolality) |
-0.88; -0.18 | — |
Summary
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 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 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, 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 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.
Data sourced from ClinicalTrials.gov (NCT00756977). 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.