- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01145222
Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy
A Phase IIb Study Evaluating the Safety and Efficacy of Multiple Doses of CNS 7056 Compared to Midazolam in Patients Undergoing Colonoscopy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a double-blind, randomized, parallel group, dose-response study to assess the safety and efficacy of three dose levels of CNS 7056 compared with midazolam to maintain suitable sedation levels in patients undergoing colonoscopy.
Safety assessment will include physical examinations, vital signs, ECGs, pulse oximetry measurements, capnography, clinical chemistry and hematology laboratory tests, routine drug and ethanol screening, urinalysis, pregnancy test, pain on injection using a verbal scale, and monitoring of adverse events.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
-
Sheffield, Alabama, United States, 35660
- Helen Keller Hospital
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Arizona
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Phoenix, Arizona, United States, 85050
- Hope Research Institute
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California
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Anaheim, California, United States, 92801
- ACRI Phase I LLC
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Anaheim, California, United States, 92801
- Advanced Clinical Research Associates
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Florida
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South Miami, Florida, United States, 33143
- Miami Research Associates
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New York
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Stony Brook, New York, United States, 11794
- Stony Brook University Medical Center
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North Carolina
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Raleigh, North Carolina, United States, 27612
- Wake Research Associates
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Oklahoma
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Tulsa, Oklahoma, United States, 74104
- Options Health Research
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Virginia
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Charlottesville, Virginia, United States, 22911
- Charlottesville Medical Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A. Remimazolam (CNS 7056)
Initial 8 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. |
Initial low dose plus supplemental doses as necessary.
Other Names:
|
Experimental: B. Remimazolam (CNS 7056)
Initial 7 mg iv for sedation induction, and 2 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. |
Initial intermediate dose plus supplemental doses as necessary.
Other Names:
|
Experimental: C. Remimazolam (CNS 7056)
Initial 5 mg iv for sedation induction, and 3 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses. |
Initial high dose plus supplemental doses as necessary.
Other Names:
|
Active Comparator: D. Midazolam
Initial 2.5 mg iv for sedation induction, and 1 mg iv top-ups for sedation maintenance. Fentanyl pre-treatment: up to 100 μg (at the discretion of the investigator) and 25 μg top-up doses |
Initial standardized dose plus supplemental doses as necessary.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success Rates of the Procedure
Time Frame: From start of study drug injection to patient discharge
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Success of the procedure is a composite endpoint consisting of: Modified Observer's Assessment for Alertness/Sedation (MOAA/S) scores ≤4 on three consecutive measurements after administration of study drug AND completion of the endoscopy procedure AND no requirement for rescue sedative medication AND no requirement for manual or mechanical ventilation
|
From start of study drug injection to patient discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Fully Alert
Time Frame: From last injection of double-blind study medication until fully alert criteria are reached
|
Time to first of 3 consecutive MOAA/S scores of 5 after the last injection of double-blind study medication
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From last injection of double-blind study medication until fully alert criteria are reached
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Time to Ready for Discharge
Time Frame: After the Last Injection of Double-Blind Study Medication AND after end of colonoscopy until first of 3 consecutive Aldrete scores ≥ 9
|
Time of the first of 3 consecutive Aldrete scores ≥ 9
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After the Last Injection of Double-Blind Study Medication AND after end of colonoscopy until first of 3 consecutive Aldrete scores ≥ 9
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Midazolam
Other Study ID Numbers
- CNS 7056-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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