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A Safety Study of 3 Different Bowel Cleansing Preparations
NCT01501513 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 541 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Braintree Laboratories, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01501513 reports 17 study locations spanning 12 distinct geographic areas — top geographies include Florida, North Carolina, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01501513?
This trial is sponsored by Braintree Laboratories, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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