A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients

September 28, 2020 updated by: Paion UK Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

461

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36688
        • University of South Alabama
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Chula Vista, California, United States, 91910
        • Precision Research Institute
      • San Diego, California, United States, 92114
        • Precision Research Institute
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Borland-Grover Clinic, P.A
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners Inc
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Medical College
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients, aged ≥18, scheduled to undergo a diagnostic or therapeutic colonoscopy (therapeutic procedures could include hemostasis, resection, ablation decompression, foreign body extraction, for example).
  • American Society of Anesthesiologists Score 1 through 3
  • Body mass index ≤40 kg/m2.
  • For female patients with child-bearing potential, negative result of pregnancy test (serum or urine) as well as use of birth control during the study period (from the time of consent until all specified observations were completed).
  • Patient voluntarily signed and dated an informed consent form that was approved by an Independent Review Board prior to the conduct of any study procedure.
  • Patient was willing and able to comply with study requirements and return for a Follow-up Visit on Day 4 (+3/-1 days) after the colonoscopy.

Exclusion Criteria:

  • Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
  • Chronic use of benzodiazepines for any indication (eg, insomnia, anxiety, spasticity).
  • Chronic use of opioids for any indication.
  • Female patients with a positive serum human chorionic gonadotropin pregnancy test at screening or baseline.
  • Lactating female patients.
  • Patients with positive drugs of abuse screen or a positive serum ethanol at baseline.
  • Patient with a history of drug or ethanol abuse within the past 2 years.
  • Patients in receipt of any investigational drug within 30 days or less than seven half-lives (whichever was longer) before screening, or scheduled to receive one during the study period.
  • Participation in any previous clinical trial with remimazolam.
  • Patients with an inability to communicate well in English with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remimazolam

Remimazolam iv 5 mg for sedation induction, and 2.5 mg top-ups for sedation maintenance.

Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses
Drug: Remimazolam
For induction and maintenance of sedation
Other Names:
  • Byfavo, CNS7056
Placebo Comparator: Placebo

Inactive control arm

Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses
Drug: Placebo
Inactive control arm
Active Comparator: Midazolam

Midazolam iv 1.75 mg* for sedation induction and 1.0 mg* for sedation maintenance.

*1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill

Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses
Drug: Midazolam
For induction of maintenance and sedation
Other Names:
  • Versed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rates of the Procedure
Time Frame: From administration of the first dose of the study drug to the end of colonoscopy
Success of the Procedure is measured by completion of colonoscopy, no requirement for an alternative sedative and no requirement for more than 5 top-ups of study medication within any 15 minute period in the blinded arms (remimazolam/placebo) or no requirement for more than 3 doses within any 12 minute window in the midazolam arm.
From administration of the first dose of the study drug to the end of colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Start of Procedure
Time Frame: From first dose of study drug until insertion of the colonoscope
The time to the start of the procedure after administration of the first dose of randomized study drug
From first dose of study drug until insertion of the colonoscope
Time to Fully Alert
Time Frame: From the end of colonoscopy (colonoscope out) until the patient has recovered to fully alert and from the last injection of the study drug or rescue sedative medication until the patient has recovered to fully alert
The time to fully alert (time to first of three consecutive Modified Observer's Assessment of Alertness/Sedation [MOAA/S] scores of 5) after the end of colonoscopy procedure [colonoscope out], and after the last dose of study drug or rescue sedative medication
From the end of colonoscopy (colonoscope out) until the patient has recovered to fully alert and from the last injection of the study drug or rescue sedative medication until the patient has recovered to fully alert
Time to Ready for Discharge
Time Frame: From the end of the colonoscopy until discharge (expected to be the same day). After the last dose of study drug or rescue sedative, until discharge (expected to be the same day).
The time after the end of colonoscopy procedure (colonoscope out) and after the last injection of study drug or rescue sedative medication, until discharge (defined as ability to walk unassisted).
From the end of the colonoscopy until discharge (expected to be the same day). After the last dose of study drug or rescue sedative, until discharge (expected to be the same day).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paion UK Ltd.

Collaborators

Premier Research Group plc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 19, 2016

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 11, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNS7056-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colonoscopy

Clinical Trials on Remimazolam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe