Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers
Effects of Gaba-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers
2 other identifiers
interventional
17
1 country
1
Brief Summary
The investigators will use an intradermal capsaicin injection in the forearm to induce a state of localized pain. This localized pain will be measured by different means, and analysed locally and distally by so called quantitative sensory testing. The primary endpoint of measure is the difference in pain perception with and without benzodiazepines/GABA-Agonists around the injection point of capsaicin. The secondary endpoints are to measure pain modulation locally and distally by different quantitative tests as electricity, pressure pain thresholds, and ice water tests. The investigators' hypothesis is that clobazam induces higher pain thresholds as placebo and less sedation than the control medication clonazepam.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 pain
Started Dec 2009
Shorter than P25 for phase_3 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2009
CompletedFirst Posted
Study publicly available on registry
November 11, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedAugust 11, 2010
August 1, 2010
4 months
November 6, 2009
August 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
area of hyperalgesia on the forearm
11.2010
Secondary Outcomes (8)
Diffuse noxious inhibition control
11.2010
Pressure cuff algometry
11.2010
pressure pain
11.2010
electrical stimulation-temporal summation
11.2010
psychomotor testing
11.2010
- +3 more secondary outcomes
Study Arms (3)
1
OTHER2
OTHER3
OTHERInterventions
Eligibility Criteria
You may qualify if:
- European males
- years old
- non smoking status or less than 10 cigarettes per day
- no disease
You may not qualify if:
- any medication
- any drug abuse
- diseases of any type
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dep of Anesthesiology and Pain Therapy, University Hospital Bern
Bern, 3010, Switzerland
Related Publications (1)
Vuilleumier PH, Besson M, Desmeules J, Arendt-Nielsen L, Curatolo M. Evaluation of anti-hyperalgesic and analgesic effects of two benzodiazepines in human experimental pain: a randomized placebo-controlled study. PLoS One. 2013;8(3):e43896. doi: 10.1371/journal.pone.0043896. Epub 2013 Mar 15.
PMID: 23554851DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michele Curatolo, Professor
University of Bern
- PRINCIPAL INVESTIGATOR
Pascal H Vuilleumier, Dr med
University of Bern
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 6, 2009
First Posted
November 11, 2009
Study Start
December 1, 2009
Primary Completion
April 1, 2010
Study Completion
June 1, 2010
Last Updated
August 11, 2010
Record last verified: 2010-08