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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.
 
ClinicalTrials.gov Identifier: NCT02290873
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : November 9, 2018
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Paion UK Ltd.

Tracking Information
First Submitted Date  ICMJE November 7, 2014
First Posted Date  ICMJE November 14, 2014
Results First Submitted Date  ICMJE October 10, 2018
Results First Posted Date  ICMJE November 9, 2018
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE March 30, 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
Success of Procedure [ Time Frame: From start to end of colonoscopy ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • Time to Start of Procedure [ Time Frame: From first dose of study drug until insertion of the colonoscope ]
  • Time to peak sedation [ Time Frame: From first dose of study drug until the lowest level of sedation, which has occurred during the colonoscopy procedure. ]
  • Time to Ready for Discharge [ Time Frame: From the end of the colonoscopy and after the last dose of study drug, until discharge, expected to be the same day. ]
  • Time to Fully Alert [ Time Frame: From the last dose of study drug, until the patient has recovered to fully alert. Expected to be the same day. ]
  • Number of patients with adverse events [ Time Frame: From first dose of study drug until Day 4, or resolution of any ongoing adverse events. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colonoscopy
Intervention  ICMJE
  • Drug: Remimazolam
    For induction and maintenance of sedation
    Other Name: Byfavo, CNS7056
  • Drug: Midazolam
    For induction of maintenance and sedation
    Other Name: Versed
  • Drug: Placebo
    Inactive control arm
Study Arms  ICMJE
  • 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

    Intervention: Drug: Remimazolam
  • Placebo Comparator: Placebo

    Inactive control arm

    Fentanyl pre-treatment: 50 μg (or less for elderly/disabled subjects) and 25 μg top-up doses

    Intervention: Drug: Placebo
  • 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

    Intervention: Drug: Midazolam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2016)
461
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2014)
460
Actual Study Completion Date  ICMJE April 19, 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02290873
Other Study ID Numbers  ICMJE CNS7056-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paion UK Ltd.
Study Sponsor  ICMJE Paion UK Ltd.
Collaborators  ICMJE Premier Research Group plc
Investigators  ICMJE
Principal Investigator: Douglas K Rex, MD Indiana University School of Medicine
PRS Account Paion UK Ltd.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP