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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01501513
The ClinicalTrials.gov registry entry for NCT01501513 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 541 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 475-participant average among 20 other Colonoscopy trials with a reported enrollment target (14% higher). The listed sponsor is Braintree Laboratories, which has 49 total studies on file at ClinicalTrials.gov.
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 reports 17 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Related
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