Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy
Condition: Sedation
Intervention: A. CNS 7056; B. CNS 7056; C. CNS 7056; D. Midazolam
Intervention description: Initial low dose plus supplemental doses as necessary.; Initial intermediate dose plus supplemental doses as necessary.; Initial high dose plus supplemental doses as necessary.; Initial standardized dose plus supplemental doses as necessary.
Intervention MeSH terms: Midazolam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: CNS 7056; Procedural Sedation; Colonoscopy

Summary:

      The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056
      compared with midazolam to maintain suitable sedation levels in patients undergoing
      colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients, aged 18 to 70 years inclusive, scheduled to undergo a
             standard colonoscopy.

          -  American Society of Anesthesiologists Physical Status (ASA PS) Score I, II, or III.

          -  Weight range 55 to 130 kg inclusive.

          -  Body mass index (BMI) range 18 to 33 kg/m2 inclusive

          -  Patients of child-bearing potential and their partners must have been willing to use
             adequate contraception such as an intrauterine device, diaphragm or condom during the
             study and until 1 month after the last study drug administration. Childbearing
             potential was defined as "all patients unless they were a female post menopausal for
             at least 2 years, or were surgically sterile."

          -  Patient voluntarily signed and dated an ICF that was approved by an IRB 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 (Day 4 ± 3 day) after the colonoscopy.

        Exclusion Criteria:

          -  Expected duration of colonoscopy > 30 minutes.

          -  Patients with a suspected or diagnosed pathology of the lower GI tract that would have
             added to the risk of colonoscopy, such as strictures, active inflammatory bowel
             disease.

          -  ASA III patients with history of sleep apnea.

          -  ASA III patients with obesity (BMI ≥ 30 kg/m2).

          -  Patients with evidence of uncontrolled renal, hepatic, central nervous system,
             respiratory, cardiovascular or metabolic dysfunction, or other clinically significant
             (CS) findings at screening that, in the investigator's or medical monitor's opinion,
             should have excluded them from the study.

          -  Patients with clinically significant abnormalities in 12 lead ECG recorded at
             screening.

          -  Female patients with a positive serum human chorionic gonadotropin (HCG) pregnancy
             test at screening or baseline.

          -  Lactating female patients.

          -  Patients with positive drugs of abuse screen at baseline.

          -  Patients with positive serum ethanol at baseline.

          -  Patient with a history of drug or ethanol abuse.

          -  Patients in receipt of any investigational drug within 30 days or less than 7 half
             lives (whichever was longer) before the start of the study, or scheduled to receive
             one during the study period.

          -  Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone,
             or a medical condition such that these agents were contraindicated.

          -  Patients with an inability to communicate well with the investigator.

          -  Patients in whom management of airway was judged to be difficult due to, e.g.,
             thyro-mental distance ≤ 4 cm ("short neck"), or Mallampati score of 4.