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

May 27, 2010
August 4, 2011
May 2010
September 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01145222 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sedation
  • Drug: A. CNS 7056
    Initial low dose plus supplemental doses as necessary.
    Other Name: CAS No. 1001415-66-2
  • Drug: B. CNS 7056
    Initial intermediate dose plus supplemental doses as necessary.
    Other Name: CAS No. 1001415-66-2
  • Drug: C. CNS 7056
    Initial high dose plus supplemental doses as necessary.
    Other Name: CAS No. 1001415-66-2
  • Drug: D. Midazolam
    Initial standardized dose plus supplemental doses as necessary.
    Other Name: CAS No. 59467-96-8
  • Experimental: A. CNS 7056
    Intervention: Drug: A. CNS 7056
  • Experimental: B. CNS 7056
    Intervention: Drug: B. CNS 7056
  • Experimental: C. CNS 7056
    Intervention: Drug: C. CNS 7056
  • Active Comparator: D. Midazolam
    Intervention: Drug: D. Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
October 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01145222
CNS 7056-004
No
Jim Lees, Clinical Development Manager, PAION UK Ltd.
Paion UK Ltd.
Not Provided
Study Director: Jim P. Lees, B.Sc. MedSci Paion UK Ltd.
Paion UK Ltd.
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP