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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: Completed Phase 3 study of Colon Cancer and Colorectal Carcinoma, sponsored by Norgine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e., all mucosa could be visualised) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus Trisulfate solution was evaluated using a non-inferiority study design.
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 |
What the finished NCT02254486 record still lists
NCT02254486 is an interventional study that assigns participants to a tested intervention. The registered 621 participants enrollment target is mid-sized for trials with a published cap, below the 4,450-participant average among 97 other Colon Cancer trials with a reported enrollment target (86% lower).
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 lists 12 locations in 7 states (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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Where NCT02254486's enrollment target sits among peer trials
621 18th of 97 higher than 80 of 97 other Colon Cancer trials
participants (enrollment target), bucketed by value
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