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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Paion UK Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	A. CNS 7056	Initial low dose plus supplemental doses as necessary.
DRUG	B. CNS 7056	Initial intermediate dose plus supplemental doses as necessary.
DRUG	C. CNS 7056	Initial high dose plus supplemental doses as necessary.
DRUG	D. Midazolam	Initial standardized dose plus supplemental doses as necessary.

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-09-01
• Completion: 2010-10-01
• First posted: 2010-06-16
• Last updated: 2019-01-08
• Results posted: 2019-01-08

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study