MedTrace Logo

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

NCT01145222 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2019-01-08

Study results available
· View outcomes & findings →

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.

Conditions

  • Sedation

Interventions

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.

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Paion UK Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-09-30
Completion
2010-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01145222 on ClinicalTrials.gov