Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01501513 · ClinicalTrials.gov registry record · Phase 3
A Safety Study of 3 Different Bowel Cleansing Preparations
A Phase 3 study of Colonoscopy and Endoscopy, sponsored by Braintree Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 541
- Enrollment target
- 17
- Study locations
NCT01501513: Completed Phase 3 study of Colonoscopy and Endoscopy, sponsored by Braintree Laboratories.
NCT01501513 is a Phase 3 study of Colonoscopy and Endoscopy that has completed, run by Braintree Laboratories. The registered enrollment target is 541 participants, above the 475-participant average among 20 other Colonoscopy trials with a reported enrollment target (14% higher). The trial reports 17 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01501513, a Phase 3 study of Colonoscopy and Endoscopy, has completed, sponsored by Braintree Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 541 participants
- Enrollment target
- 17
- Study locations
Study Summary
The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.
Primary Outcome
Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).
Conditions Studied
Interventions
- DRUG PEG-3350 based bowel preparation
- DRUG BLI800 approved preparation regimen
- DRUG BLI800 investigational preparation regimen
Study Locations (17)
Florida
- Mayo Clinic Jacksonville - Jacksonville
- Borland-Groover Clinic - Jacksonville
- Miami Research Associates - South Miami
North Carolina
- Asheville Gastroenterology Associates - Asheville
- Carolina Digestive Health Associates - Charlotte
- Wake Research Associates - Raleigh
Tennessee
- ClinSearch - Chattanooga
- Franklin Gastroenterology - Franklin
Alabama
- University of South Alabama - Mobile
California
- Advanced Clinical Research Institute - Anaheim
Indiana
- Indiana University - Indianapolis
Louisiana
- Delta Research Partners - Monroe
Massachusetts
- Commonwealth Clinical Studies - Brockton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 541 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-03-04 |
| Phase | Phase 3 |
What the finished NCT01501513 record still lists
NCT01501513 is an interventional study that assigns participants to a tested intervention. The registered 541 participants enrollment target is mid-sized for trials with a published cap, above the 475-participant average among 20 other Colonoscopy trials with a reported enrollment target (14% higher).
The record links to 3 conditions, with Colonoscopy appearing as the primary indexed condition, and to 3 interventions - of which PEG-3350 based bowel preparation is the first listed.
NCT01501513 lists 17 locations in 12 states (Florida, North Carolina, Tennessee).
Frequently Asked Questions
What is clinical trial NCT01501513 about?
NCT01501513 is a clinical study titled "A Safety Study of 3 Different Bowel Cleansing Preparations". The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impai...
What is the current status of trial NCT01501513?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 541 participants. The study started on 2011-12. Estimated completion is 2013-03-04.
What conditions does trial NCT01501513 study?
This clinical trial studies the following conditions: Colonoscopy, Endoscopy, Bowel Preparation.
What interventions are being tested in trial NCT01501513?
The interventions under investigation include: PEG-3350 based bowel preparation (DRUG), BLI800 approved preparation regimen (DRUG), BLI800 investigational preparation regimen (DRUG).
Who is sponsoring clinical trial NCT01501513?
This trial is sponsored by Braintree Laboratories, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01501513 being conducted?
This trial has 17 study locations across Alabama, California, Florida, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colonoscopy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01501513's enrollment target sits among peer trials
541 4th of 20 higher than 17 of 20 other Colonoscopy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colonoscopy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients
COMPLETED · Phase 3
-
HalfLytely Bowel Prep System for Colonoscopy
COMPLETED · Phase 3
-
Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
COMPLETED · Phase 3
-
BLI-800-301: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
COMPLETED · Phase 3
-
Can Nitrous Oxide (Laughing Gas) be Used as a Sedative for GI Endoscopy Procedures?
RECRUITING · Phase 4
-
Can Overall Adenoma Detection Rate Replace Screening Adenoma Detection Rate ? Multicenter Study
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04929223 · 542 participants · Phase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
- NCT05584670 · 542 participants · Phase 1
A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
- NCT04557462 · 540 participants · Phase 3
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
- NCT04956640 · 540 participants · Phase 1
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia