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

2014-08-27 03:12:50 | BioPortfolio

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.

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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Sedation

Intervention

A. CNS 7056, B. CNS 7056, C. CNS 7056, D. Midazolam

Location

Helen Keller Hospital
Sheffield
Alabama
United States
35660

Status

Recruiting

Source

Paion UK Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:50-0400

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PubMed Articles [249 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

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A cytochrome P-450 monooxygenase that is involved in an NADPH-dependent electron transport pathway by oxidizing a variety of structurally unrelated compounds, including STEROIDS; FATTY ACIDS; and XENOBIOTICS. This enzyme has clinical significance due to its ability to metabolize a diverse array of clinically important drugs such as CYCLOSPORINE; VERAPAMIL; and MIDAZOLAM. This enzyme also catalyzes the N-demethylation of ERYTHROMYCIN.

Drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposely following repeated painful stimulation. The ability to independently maintain ventilatory function may be impaired. (From: American Society of Anesthesiologists Practice Guidelines)

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