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



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:11/11/2018
Start Date:March 30, 2015
End Date:April 19, 2016

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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.

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.


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).
We found this trial at
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Anaheim, California 92801
Phone: 714-774-7777
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
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Chula Vista, California 91910
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Indianapolis, Indiana 46202
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4800 Belfort Road
Jacksonville, Florida 32256
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307 N University Blvd
Mobile, Alabama 36688
(251) 460-6101
University of South Alabama "University of South Alabama is a public institution that was founded...
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Monroe, Louisiana 71201
Phone: 318-807-0819
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Nashville, Tennessee 37205
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Philadelphia, Pennsylvania 19107
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Diego, California 92115
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