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NCT02290873 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients
A Phase 3 study of Colonoscopy, sponsored by Paion UK.
- Completed
- Registry status
- Phase 3
- Development phase
- 461
- Enrollment target
- 13
- Study locations
NCT02290873: Completed Phase 3 study of Colonoscopy, sponsored by Paion UK.
NCT02290873 is a Phase 3 study of Colonoscopy that has completed, run by Paion UK. The registered enrollment target is 461 participants, roughly in line with the 479-participant average among 20 other Colonoscopy trials with a reported enrollment target. The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02290873, a Phase 3 study of Colonoscopy, has completed, sponsored by Paion UK.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 461 participants
- Enrollment target
- 13
- Study locations
Study Summary
A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons.
Primary Outcome
Success of the Procedure is measured by completion of colonoscopy, no requirement for an alternative sedative and no requirement for more than 5 top-ups of study medication within any 15 minute period in the blinded arms (remimazolam/placebo) or no requirement for more than 3 doses within any 12 minute window in the midazolam arm.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Midazolam
- DRUG Remimazolam
Study Locations (13)
California
- Advanced Clinical Research Institute - Anaheim
- Precision Research Institute - Chula Vista
- Precision Research Institute - San Diego
Alabama
- University of South Alabama - Mobile
Florida
- Borland-Grover Clinic, P.A - Jacksonville
Indiana
- Indiana University Health - Indianapolis
Louisiana
- Delta Research Partners Inc - Monroe
Missouri
- Washington University School of Medicine - St Louis
North Carolina
- Wake Research Associates - Raleigh
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 461 participants |
| Start Date | 2015-03-30 |
| Est. Completion | 2016-04-19 |
| Phase | Phase 3 |
What the finished NCT02290873 record still lists
NCT02290873 is an interventional study that assigns participants to a tested intervention. The registered 461 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 479-participant average among 20 other Colonoscopy trials with a reported enrollment target.
The record links to 1 condition, with Colonoscopy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02290873 lists 13 locations in 11 states (California, Alabama, Florida).
Frequently Asked Questions
What is clinical trial NCT02290873 about?
NCT02290873 is a clinical study titled "A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients". A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons.
What is the current status of trial NCT02290873?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 461 participants. The study started on 2015-03-30. Estimated completion is 2016-04-19.
What conditions does trial NCT02290873 study?
This clinical trial studies the following conditions: Colonoscopy.
What interventions are being tested in trial NCT02290873?
The interventions under investigation include: Placebo (DRUG), Midazolam (DRUG), Remimazolam (DRUG).
Who is sponsoring clinical trial NCT02290873?
This trial is sponsored by Paion UK, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02290873 being conducted?
This trial has 13 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 NCT02290873's enrollment target sits among peer trials
461 7th of 20 higher than 14 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.
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