At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 461 enrolled
Drug / intervention
Remimazolam +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Remimazolam, Midazolam, and 1 other intervention for Colonoscopy. Completed, enrolled 461 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColonoscopy
CountriesUnited States
CollaboratorsPremier Research
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartMar 2015
Primary CompletionApr 2016
Study CompletionApr 2016
TodayJul 2026
First PostedNov 14, 2014
Enrollment StartMar 30, 2015
Primary CompletionApr 1, 2016
Study CompletionApr 19, 2016
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 11.6 years ago
Interventions
Remimazolamdrug
For induction and maintenance of sedation
Midazolamdrug
For induction of maintenance and sedation
Placebodrug
Inactive control arm