Phase 3
Completed N=371
BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Source: ClinicalTrials.gov NCT00756548 ↗Enrolled (actual)
371
Serious AEs
0.3%
Results posted
Dec 2013
Primary outcomePrimary: Efficacy - Preparation Quality Using a 4 Point Scale — 94; 94 percentage of participants
Summary
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy - Preparation Quality Using a 4 Point Scale |
94; 94 | — |
| SECONDARY Serum Chemistry Results (mEq/L) |
0.39; 0.92; -0.23; -1.69; -0.01; 1.58 | — |
| SECONDARY Hematology Results (%) |
-0.00; -0.01; -0.06; -0.08; 0.31; 0.33 | — |
| SECONDARY Serum Chemistry Results (U/L) |
2.13; 0.67; 4.34; 3.86; -9.98; -6.55 | — |
| SECONDARY Serum Chemistry Results (mg/dL) |
-3.91; -3.01; -0.14; -0.17; 0.05; 0.00 | — |
| SECONDARY Serum Chemistry Results (g/dL) |
0.07; 0.05; 0.13; 0.10 | — |
| SECONDARY Serum Chemistry Results - Glomerular Filtration Rate |
-0.53; -0.23 | — |
| SECONDARY Hematology Results - Hemoglobin |
0.22; 0.12 | — |
| SECONDARY Hematology Results (1000/MCL) |
0.69; -1.00; -0.39; -0.48 | — |
| SECONDARY Hematology Results - Red Blood Cells |
0.07; 0.03 | — |
| SECONDARY Serum Chemistry Results (Osmolality) |
-2.12; -0.11 | — |
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, intra-uterine device, 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 (NCT00756548). 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. Informational only — not medical advice.