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Safety and Efficacy of Remimazolam in ASA III and IV Patients Undergoing Colonoscopy

NCT02532647 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2020-09-30

Study results available
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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

  • Colonoscopy

Interventions

DRUG

Remimazolam

DRUG

Midazolam

DRUG

Placebo

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Paion UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Douglas Rex, MD · IU Health University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-12-31
Completion
2016-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02532647 on ClinicalTrials.gov