CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
CNS 7056 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00869440
NCT00869440Phase 2Completed

A Phase IIa, Randomized, Controlled, Double-Blind, Dose-Finding Study Evaluating the Safety and Pharmacodynamics of CNS 7056 in Patients Undergoing Diagnostic Upper GI Endoscopy

Paion UK Ltd.·interventional·Posted Mar 26, 2009·Updated Jan 8, 2019

In Brief

A Phase 2 clinical trial evaluating CNS 7056 and Midazolam for Procedural Sedation and Endoscopy. Completed, enrolled 100 participants across 7 sites.

Detailed Summary

The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPremier Research

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2009
Enrollment StartMar 1, 2009
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.3 years ago

Interventions

CNS 7056drug

Administered as a single intravenous injection by a syringe driver over 1 minute

Midazolamdrug

Administered as a single intravenous injection by a syringe driver over 1 minute