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NCT02254486 · ClinicalTrials.gov registry record · Phase 3
Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults
A Phase 3 study of Colon Cancer and Colorectal Carcinoma, sponsored by Norgine.
- Completed
- Registry status
- Phase 3
- Development phase
- 621
- Enrollment target
- 12
- Study locations
NCT02254486 is a Phase 3 study of Colon Cancer and Colorectal Carcinoma that has completed, run by Norgine. The registered enrollment target is 621 participants, below the 4,450-participant average among 97 other Colon Cancer trials with a reported enrollment target (86% lower). The trial reports 12 study locations across 7 states.
The verdict
NCT02254486, a Phase 3 study of Colon Cancer and Colorectal Carcinoma, has completed, sponsored by Norgine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 621 participants
- Enrollment target
- 12
- Study locations
Study Summary
This study evaluates the efficacy, safety and tolerability of NER1006 versus Trisulfate Solution (TS) in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing regimen. Approximately 540 patients will be randomised with the aim of achieving a minimum of 245 patients in each of the 2 groups.
Conditions Studied
Interventions
- DRUG NER1006
- DRUG Trisulfate solution
Study Locations (12)
North Carolina
- Cumberland Research Associates, LLC - Fayetteville
- Peters Medical Research - High Point
- Wake Research Associates, LLC - Raleigh
- Trial Management Associates, LLC - Wilmington
Maryland
- Investigative Clinical Research - Annapolis
- MGG Group Co., Inc., Chevy Chase Clinical - Chevy Chase
Ohio
- Consultants for Clinical Research - Cincinnati
- Investigative Clinical Research, LLC - Mentor
California
- Anaheim Clinical Trials - Anaheim
Michigan
- Clinical Research Institute of Michigan, LLC - Chesterfield
New York
- Long Island Gastrointestinal Research Group, LLP - Great Neck
Utah
- Advanced Research Institute - Ogden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 621 participants |
| Start Date | 2014-09 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02254486
The ClinicalTrials.gov registry entry for NCT02254486 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 621 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,450-participant average among 97 other Colon Cancer trials with a reported enrollment target (86% lower). The listed sponsor is Norgine, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Colon Cancer appearing as the primary indexed condition, and to 2 interventions - of which NER1006 is the first listed.
NCT02254486 reports 12 study locations spanning 7 distinct geographic areas - top geographies include North Carolina, Maryland, Ohio.
Frequently Asked Questions
What is clinical trial NCT02254486 about?
NCT02254486 is a clinical study titled "Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults". This study evaluates the efficacy, safety and tolerability of NER1006 versus Trisulfate Solution (TS) in adult patients requiring bowel cleansing prior to any procedure that requires a clean bowel, using a 2-Day evening/morning Split-Dosing regimen. Approximately 540 patients will be randomised with...
What is the current status of trial NCT02254486?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 621 participants. The study started on 2014-09. Estimated completion is 2015-06.
What conditions does trial NCT02254486 study?
This clinical trial studies the following conditions: Colon Cancer, Colorectal Carcinoma, Colon Cleansing.
What interventions are being tested in trial NCT02254486?
The interventions under investigation include: NER1006 (DRUG), Trisulfate solution (DRUG).
Who is sponsoring clinical trial NCT02254486?
This trial is sponsored by Norgine, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02254486 being conducted?
This trial has 12 study locations across California, Maryland, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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