Analgesic Effects of Midazolam in Human Volunteers (GabA01)

March 10, 2016 updated by: Burkhard Gustorff, Wilhelminenspital Vienna

A Single Center, Prospective, Randomized, Double Blind, Placebo-controlled, Three-way Cross-over Study of the Analgesic Effects of Midazolam Versus Placebo With Fentanyl as an Active Control in Human Volunteers

This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each participant will receive all three drugs (midazolam, fentanyl, placebo) on three different occasions (study visits) and the effect on different pain stimuli will be tested.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1190
        • Schmerzdiagnostik / Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male and female volunteers
  • 18-40 years old
  • healthy
  • body mass index between 5th and 85th percentile
  • Caucasian
  • non smoker or moderate smoker (<10 cigarettes per day)
  • able to understand, write, and read German

Exclusion Criteria:

  • acute or chronic pain condition (except for mild day-to-day pain on <5 days/month)
  • previous (up to 5 days preceding the study) or current medications prescription or over-the-counter, especially analgesics
  • symptoms of a clinically relevant illness in the 2 weeks before the first study day
  • hypertension
  • any known psychiatric condition
  • abuse of alcoholic beverages, drug abuse
  • known positive human immunodeficiency virus status
  • any known medical condition which may interact with study medication, study objectives, or compliance of subject with study tasks
  • participation in a clinical trial in the 4 weeks preceding the study
  • known allergy against Midazolam
  • known allergy against Fentanyl
  • pregnancy or breast-feeding
  • unable or unwilling to give informed consent
  • unable or unwilling to follow investigator's instructions
  • unable or unwilling to comply with study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Midazolam
Drug: Midazolam (experimental)
Drug: Midazolam
Other Names:
  • Dormicum
Placebo Comparator: Isotonic saline
Drug: Isotonic saline (placebo)
Drug: Isotonic saline
Active Comparator: Fentanyl
Drug: Fentanyl (active comparator)
Drug: Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pain ratings (0-100) to a suprathreshold heat pain stimulus
Time Frame: 3.5 Minutes after end of infusion
3.5 Minutes after end of infusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in pain ratings to a suprathreshold electrical pain stimulus
Time Frame: 3.5 Minutes after end of infusion
3.5 Minutes after end of infusion
Increase of pressure pain thresholds (kPa)
Time Frame: Up until 23 Minutes after end of infusion
Up until 23 Minutes after end of infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wilhelminenspital Vienna

Collaborators

Akron Molecules AG

Investigators

  • Principal Investigator: Burkhard Gustorff, Prof.Dr., Wilhelminenspital Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 6, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 14, 2015

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GabA01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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