A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients
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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. |
| ClinicalTrials.gov Identifier: NCT02290873 |
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Recruitment Status :
Completed
First Posted : November 14, 2014
Results First Posted : November 9, 2018
Last Update Posted : October 20, 2020
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Sponsor:
Paion UK Ltd.
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Paion UK Ltd.
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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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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 |
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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 |
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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 :
- 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 :
- 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
- 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
- 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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 ClinicalTrials.gov identifier (NCT number): NCT02290873
Locations
| 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
Investigators
| Principal Investigator: | Douglas K Rex, MD | Indiana University School of Medicine |
Publications of Results:
Other Publications:
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:
| Responsible Party: | Paion UK Ltd. |
| ClinicalTrials.gov 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 |
| 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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Midazolam Adjuvants, Anesthesia Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs |
Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |