A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients
NCT ID: NCT02290873
Last Updated: 2020-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
461 participants
INTERVENTIONAL
2015-03-30
2016-04-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Remimazolam
For induction and maintenance of sedation
Placebo
Inactive control arm
Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses
Placebo
Inactive control arm
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
Midazolam
For induction of maintenance and sedation
Interventions
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Remimazolam
For induction and maintenance of sedation
Midazolam
For induction of maintenance and sedation
Placebo
Inactive control arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Premier Research Group plc
UNKNOWN
Paion UK Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas K Rex, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Locations
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University of South Alabama
Mobile, Alabama, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Precision Research Institute
Chula Vista, California, United States
Precision Research Institute
San Diego, California, United States
Borland-Grover Clinic, P.A
Jacksonville, Florida, United States
Indiana University Health
Indianapolis, Indiana, United States
Delta Research Partners Inc
Monroe, Louisiana, United States
Washington University School of Medicine
St Louis, Missouri, United States
Wake Research Associates
Raleigh, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Thomas Jefferson Medical College
Philadelphia, Pennsylvania, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
Countries
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References
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Antonik LJ, Goldwater DR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics. Anesth Analg. 2012 Aug;115(2):274-83. doi: 10.1213/ANE.0b013e31823f0c28. Epub 2011 Dec 20.
Wiltshire HR, Kilpatrick GJ, Tilbrook GS, Borkett KM. A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part II. Population pharmacokinetic and pharmacodynamic modeling and simulation. Anesth Analg. 2012 Aug;115(2):284-96. doi: 10.1213/ANE.0b013e318241f68a. Epub 2012 Jan 16.
Worthington MT, Antonik LJ, Goldwater DR, Lees JP, Wilhelm-Ogunbiyi K, Borkett KM, Mitchell MC. A phase Ib, dose-finding study of multiple doses of remimazolam (CNS 7056) in volunteers undergoing colonoscopy. Anesth Analg. 2013 Nov;117(5):1093-100. doi: 10.1213/ANE.0b013e3182a705ae.
Borkett KM, Riff DS, Schwartz HI, Winkle PJ, Pambianco DJ, Lees JP, Wilhelm-Ogunbiyi K. A Phase IIa, randomized, double-blind study of remimazolam (CNS 7056) versus midazolam for sedation in upper gastrointestinal endoscopy. Anesth Analg. 2015 Apr;120(4):771-80. doi: 10.1213/ANE.0000000000000548.
Pambianco DJ, Borkett KM, Riff DS, Winkle PJ, Schwartz HI, Melson TI, Wilhelm-Ogunbiyi K. A phase IIb study comparing the safety and efficacy of remimazolam and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2016 May;83(5):984-92. doi: 10.1016/j.gie.2015.08.062. Epub 2015 Sep 9.
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.
Rex DK, Bhandari R, Desta T, DeMicco MP, Schaeffer C, Etzkorn K, Barish CF, Pruitt R, Cash BD, Quirk D, Tiongco F, Sullivan S, Bernstein D. A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy. Gastrointest Endosc. 2018 Sep;88(3):427-437.e6. doi: 10.1016/j.gie.2018.04.2351. Epub 2018 Apr 30.
Other Identifiers
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CNS7056-006
Identifier Type: -
Identifier Source: org_study_id
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