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

This study has been completed.
Sponsor:
Information provided by:
Paion UK Ltd.
ClinicalTrials.gov Identifier:
NCT01145222
First received: May 27, 2010
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Sedation
Drug: A. CNS 7056
Drug: B. CNS 7056
Drug: C. CNS 7056
Drug: D. Midazolam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Paion UK Ltd.:

Primary Outcome Measures:
  • To assess the success of the procedure, by a composite measurement of sedation level, procedure completion, alternative sedation required and if ventilation was necessary. [ Time Frame: From start of study drug injection to patient discharge (approx. 3 hours) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety by measurement of Adverse Events. [ Time Frame: From start of study drug injection to patient discharge (approx. 3 hours) ] [ Designated as safety issue: Yes ]
  • Measurement of Sedation levels and duration. [ Time Frame: From start of study drug injection to patient discharge (approx. 3 hours) ] [ Designated as safety issue: No ]
  • Measurement of Procedure recall and Cognitive function. [ Time Frame: From prior to study drug injection until patient completes follow-up visit (approx. 4 days) ] [ Designated as safety issue: No ]
  • Assessment of standard Pharmacokinetic parameters of CNS 7056 in human plasma. [ Time Frame: From prior to study drug injection until patient discharge (approx. 3 hours) ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A. CNS 7056 Drug: A. CNS 7056
Initial low dose plus supplemental doses as necessary.
Other Name: CAS No. 1001415-66-2
Experimental: B. CNS 7056 Drug: B. CNS 7056
Initial intermediate dose plus supplemental doses as necessary.
Other Name: CAS No. 1001415-66-2
Experimental: C. CNS 7056 Drug: C. CNS 7056
Initial high dose plus supplemental doses as necessary.
Other Name: CAS No. 1001415-66-2
Active Comparator: D. Midazolam Drug: D. Midazolam
Initial standardized dose plus supplemental doses as necessary.
Other Name: CAS No. 59467-96-8

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients 18 to 70 years of age 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
  • BMI 18 ≤33 kg/m2

Exclusion Criteria:

  • Expected duration of colonoscopy >30 minutes
  • Patients with a suspected or diagnosed pathology of the lower GI tract that would add to the risk of colonoscopy, such as strictures or 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 findings at screening that, in the investigator's or medical monitor's opinion, should exclude them from the study
  • Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents are contraindicated
  • Patients in whom management of airway is judged to be difficult due to thyro-mental distance ≤4 cm ("short neck") or Mallampati score of 4
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145222

Locations
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
Advanced Clinical Research Associates
Anaheim, California, United States, 92801
ACRI Phase I LLC
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.
Investigators
Study Director: Jim P. Lees, B.Sc. MedSci Paion UK Ltd.
  More Information

No publications provided

Responsible Party: Jim Lees, Clinical Development Manager, PAION UK Ltd.
ClinicalTrials.gov Identifier: NCT01145222     History of Changes
Other Study ID Numbers: CNS 7056-004
Study First Received: May 27, 2010
Last Updated: August 4, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 19, 2014