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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02290873
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : November 9, 2018
Last Update Posted : October 20, 2020
Premier Research Group plc
Information provided by (Responsible Party):
Paion UK Ltd.

Brief 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 colonoscopy for diagnostic or therapeutic reasons.

Condition or disease Intervention/treatment Phase
Colonoscopy Drug: Remimazolam Drug: Midazolam Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 461 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 30, 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 19, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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 Name: 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 Name: Versed

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02290873

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United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36688
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Precision Research Institute
Chula Vista, California, United States, 91910
Precision Research Institute
San Diego, California, United States, 92114
United States, Florida
Borland-Grover Clinic, P.A
Jacksonville, Florida, United States, 32256
United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Delta Research Partners Inc
Monroe, Louisiana, United States, 71201
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson Medical College
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205
United States, Virginia
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
Paion UK Ltd.
Premier Research Group plc
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Principal Investigator: Douglas K Rex, MD Indiana University School of Medicine
Publications of Results:
Douglas K. Rex, MD, MACG, Raj Bhandari, MD, Taddese Desta MD, Michael DeMicco MD, Cynthia Schaeffer MD, Kyle Etzkorn, Charles Barish MD, Ronald Pruitt MD, Brooks Cash MD, FACG, Daniel Quirk MD, Felix Tiongco MD, David Bernstein MD, FACG. REMIMAZOLAM IS A SAFE AND EFFECTIVE AGENT FOR SEDATION IN OUTPATIENT COLONOSCOPY: RESULTS OF A PHASE 3, MULTICENTER, RANDOMIZED, PLACEBO CONTROLLED TRIAL. Program No. ACG 2016 Annual Scientific Meeting Abstracts. Las Vegas, NV: American College of Gastroenterology.

Other Publications:

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Responsible Party: Paion UK Ltd. Identifier: NCT02290873    
Other Study ID Numbers: CNS7056-006
First Posted: November 14, 2014    Key Record Dates
Results First Posted: November 9, 2018
Last Update Posted: October 20, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action