At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 79 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 Study Evaluating the Safety and Efficacy of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in ASA III and IV Patients Undergoing Colonoscopy
In Brief
A Phase 3 clinical trial evaluating Remimazolam, Midazolam, and 1 other intervention for Colonoscopy. Completed, enrolled 79 participants across 3 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 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColonoscopy
CountriesUnited States
CollaboratorsPremier Research
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartNov 2015
Primary CompletionDec 2016
TodayJul 2026
First PostedAug 26, 2015
Enrollment StartNov 1, 2015
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.8 years ago
Interventions
Remimazolamdrug
Midazolamdrug
Placebodrug