Main
|
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: |
|
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
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|