A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients
Condition: Colonoscopy
Intervention: Remimazolam; Midazolam; Placebo
Intervention description: For induction and maintenance of sedation; For induction of maintenance and sedation; Inactive control arm
Intervention MeSH terms: Midazolam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 461.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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).