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Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy

NCT00869440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-01-08

Study results available
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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.

Conditions

  • Procedural Sedation
  • Endoscopy

Interventions

DRUG

CNS 7056

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

DRUG

Midazolam

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

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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-09-30
Completion
2009-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT00869440 on ClinicalTrials.gov