- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02928328
Assessment of Peripheral GABA Receptors for Local Pain Relief
Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subproject I This study will test if oral administration of GABA containing solutions will reduce the pain and sensitivity induced by application of capsaicin to the tongue of healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) for the oral cavity study.
Subproject II This study will test the hypothesis that intramuscular injection of GABA alone will not be painful, but will reduce muscle pain sensitivity in healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) will be recruited for the intramuscular GABA injection studies
Subproject III This study will test the hypothesis that intramuscular injection of GABA with glutamate will decrease the intensity of glutamate-evoked muscle pain in healthy human subjects. Thirty, pain-free men (n=15) and women (n=15) will be recruited for the intramuscular glutamate and GABA injection studies.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brian E Cairns, PhD, DrMed
- Phone Number: +45 99407521
- Email: bec@hst.aau.dk
Study Locations
-
-
-
Aalborg, Denmark, 9220
- Recruiting
- Aalborg University
-
Contact:
- Kelun Wang, DDS, PhD
- Email: kelun@hst.aau.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 20-40 years
- Free from ongoing or chronic pain
- Adequate conversational English
Exclusion Criteria:
- Pregnancy or intent to become pregnant, breast feeding
- Signs or symptoms of any serious systemic diseases
- Current malignancies
- High blood pressure
- Requirement for chronic administration of psychiatric, analgesic or other medications that might influence their response to pain
- Frequent recreational drug or alcohol use
- Previous neurologic, musculoskeletal or mental illnesses
- Lack of ability to cooperate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GABA oral solution
This study will test if oral administration of GABA containing solutions will reduce the pain and sensitivity induced by application of capsaicin to the tongue of healthy human subjects.
|
Oral mouth wash containing either GABA, lidocaine or distilled water will be used to decrease burning tongue pain produced by capsaicin
Other Names:
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Experimental: Intramuscular GABA
This study will test the hypothesis that intramuscular injection of GABA alone will not be painful, but will reduce muscle pain sensitivity in healthy human subjects.
|
The effect of intramuscular injection of GABA or lorazepam will be compared with buffered isotonic saline
Other Names:
|
Experimental: Pain modulation
This study will test the hypothesis that intramuscular injection of GABA with glutamate will decrease the intensity of glutamate-evoked muscle pain in healthy human subjects.
|
The effect of GABA alone or in combination with lorazepam on muscle pain produced by intramuscular injection of glutamate will be assessed.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity Rating
Time Frame: continuously for 95 minutes
|
visual analogue scale
|
continuously for 95 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Jaw Function Tests
Time Frame: every 5 min for 50 minutes
|
maximal jaw opening, maximal bite force
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every 5 min for 50 minutes
|
Quantitative Sensory testing
Time Frame: every 10 min for 90 min
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Pressure detection and pain threshold, thermal detection and pain threshold
|
every 10 min for 90 min
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian E Cairns, PhD DrMed, Aalborg University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Lidocaine
- gamma-Aminobutyric Acid
- Capsaicin
- Lorazepam
- Butyric Acid
Other Study ID Numbers
- N-20160037
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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