Trials / Completed
CompletedNCT02290873
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 461 (actual)
- Sponsor
- Paion UK Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Remimazolam | For induction and maintenance of sedation |
| DRUG | Midazolam | For induction of maintenance and sedation |
| DRUG | Placebo | Inactive control arm |
Timeline
- Start date
- 2015-03-30
- Primary completion
- 2016-04-01
- Completion
- 2016-04-19
- First posted
- 2014-11-14
- Last updated
- 2020-10-20
- Results posted
- 2018-11-09
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02290873. Inclusion in this directory is not an endorsement.