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A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

NCT02296892 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2020-03-18

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 patients undergoing a bronchoscopy.

Conditions

  • Bronchoscopy

Interventions

DRUG

Remimazolam

For induction and maintenance of sedation

DRUG

Placebo

Inactive control arm

DRUG

Midazolam

For induction and maintenance of sedation

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Paion UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Gerard Silvestri, MD · Medical University of South Carolina, US

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-03-31
Completion
2017-03-13
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 NCT02296892 on ClinicalTrials.gov