Clinical trial · Interventional
BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
NCT00756977CI-TRIAL-00011780completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BLI850 | Drug | — | UNRESOLVED |
| polyethylene glycol 3350 based bowel preparation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- multi-dose preparation for oral administration prior to colonoscopy
- interventionNames
- Drug: BLI850
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- multi-dose preparation for oral administration prior to colonoscopy
- interventionNames
- Drug: polyethylene glycol 3350 based bowel preparation
Primary outcomes (1)
- measure
- Efficacy - Preparation Quality Using a 4 Point Scale
- timeFrame
- 2-day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. At least 18 years of age. 3. Otherwise in good health, as determined by physical exam and medical history. 4. 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). 5. Negative urine pregnancy test at screening, if applicable. 6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study. Exclusion Criteria: 1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon. 2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration. 3. Subjects who are undergoing colonoscopy for foreign body removal or decompression. 4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results. 5. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass). 6. Subjects who are pregnant or lactating, or intending to become pregnant during the study. 7. Subjects of childbearing potential who refuse a pregnancy test. 8. Subjects who are allergic to any preparation components 9. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. 10. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
References
Publications (0)
Data not yet available
No reference posted for this study.