Trials / Completed
CompletedNCT02532647
Safety and Efficacy of Remimazolam in ASA III and IV Patients Undergoing Colonoscopy
A Study Evaluating the Safety and Efficacy of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in ASA III and IV Patients Undergoing Colonoscopy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 79 (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 American Society of Anesthesiologists (ASA) Grade III and IV patients (ASA status evaluated by an anesthesiologist not otherwise involved in the study) undergoing a colonoscopy for diagnostic or therapeutic reasons.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Remimazolam | |
| DRUG | Midazolam | |
| DRUG | Placebo |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2015-08-26
- Last updated
- 2020-09-30
- Results posted
- 2019-01-23
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02532647. Inclusion in this directory is not an endorsement.