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Trial record 12 of 13 for:    paion

Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy

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: NCT01145222
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Paion UK Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Sedation Drug: A. CNS 7056 Drug: B. CNS 7056 Drug: C. CNS 7056 Drug: D. Midazolam Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIb Study Evaluating the Safety and Efficacy of Multiple Doses of CNS 7056 Compared to Midazolam in Patients Undergoing Colonoscopy
Study Start Date : May 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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.

Drug: A. CNS 7056
Initial low dose plus supplemental doses as necessary.
Other Names:
  • CAS No. 1001415-66-2
  • Remimazolam

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.

Drug: B. CNS 7056
Initial intermediate dose plus supplemental doses as necessary.
Other Names:
  • CAS No. 1001415-66-2
  • Remimazolam

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.

Drug: C. CNS 7056
Initial high dose plus supplemental doses as necessary.
Other Names:
  • CAS No. 1001415-66-2
  • Remimazolam

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

Drug: D. Midazolam
Initial standardized dose plus supplemental doses as necessary.
Other Name: CAS No. 59467-96-8




Primary Outcome Measures :
  1. Success Rates of the Procedure [ Time Frame: From start of study drug injection to patient discharge ]
    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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT01145222


Locations
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United States, Alabama
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
United States, California
ACRI Phase I LLC
Anaheim, California, United States, 92801
Advanced Clinical Research Associates
Anaheim, California, United States, 92801
United States, Florida
Miami Research Associates
South Miami, Florida, United States, 33143
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Oklahoma
Options Health Research
Tulsa, Oklahoma, United States, 74104
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Paion UK Ltd.
Premier Research Group plc

Publications of Results:
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Responsible Party: Paion UK Ltd.
ClinicalTrials.gov Identifier: NCT01145222     History of Changes
Other Study ID Numbers: CNS 7056-004
First Posted: June 16, 2010    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paion UK Ltd.:
CNS 7056
Procedural Sedation
Colonoscopy

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