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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02928328
Date of registration: 06/10/2016
Prospective Registration: No
Primary sponsor: Aalborg University
Public title: Assessment of Peripheral GABA Receptors for Local Pain Relief
Scientific title: Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring
Date of first enrolment: October 2016
Target sample size: 90
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT02928328
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).  
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Name:     Brian E Cairns, PhD, DrMed
Address: 
Telephone: +45 99407521
Email: bec@hst.aau.dk
Affiliation: 
Name:     Kelun Wang, DDS, PhD
Address: 
Telephone:
Email: kelun@hst.aau.dk
Affiliation: 
Name:     Brian E Cairns, PhD DrMed
Address: 
Telephone:
Email:
Affiliation:  Aalborg University
Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 40 Years
Gender: All
Health Condition(s) or Problem(s) studied
Pain
Intervention(s)
Drug: GABA oral solution
Drug: Intramuscular GABA
Drug: Pain modulation
Primary Outcome(s)
Pain Intensity Rating [Time Frame: continuously for 95 minutes]
Secondary Outcome(s)
Jaw Function Tests [Time Frame: every 5 min for 50 minutes]
Quantitative Sensory testing [Time Frame: every 10 min for 90 min]
Secondary ID(s)
N-20160037
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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