PainNCT02928328
Assessment of Peripheral GABA Receptors for Local Pain Relief
A study testing GABA oral solution, Intramuscular GABA and Pain modulation in people with Pain, run by Aalborg University at 1 site in Denmark.
Trial summary
The effect of peripheral GABAA receptor activation on pain and sensitivity in healthy human subjects has never been investigated. However, as earlier studies suggest that activation of peripheral GABAA receptors is anti-nociceptive in rats, it is important to determine if these findings can be translated into human… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- GABA oral solution, Intramuscular GABA and Pain modulation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20-40 years
- Free from ongoing or chronic pain
- Adequate conversational English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University
Aalborg, 9220
Kelun Wang, DDS, PhD, kelun@hst.aau.dk
About this study
Official title: Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring
The effect of peripheral GABAA receptor activation on pain and sensitivity in healthy human subjects has never been investigated. However, as earlier studies suggest that activation of peripheral GABAA receptors is anti-nociceptive in rats, it is important to determine if these findings can be translated into human subjects to determine if peripheral GABAA receptors are a viable target for future analgesic drug development.
Read the 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.
- Conditions
- Pain
- Being tested
- GABA oral solution, Intramuscular GABA, Pain modulation
- Keywords
- craniofacial pain, masticatory muscle, burning mouth syndrome, temporomandibular disorders
- Medical subject headings
- Pain, Facial Pain, Burning Mouth Syndrome, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GABA oral solutionDrug
Also called gamma aminobutyric acid, lidocaine, distilled water, capsaicin
Oral mouth wash containing either GABA, lidocaine or distilled water will be used to decrease burning tongue pain produced by capsaicin
Intramuscular GABADrug
Also called gamma aminobutyric acid, lorazepam, buffered isotonic saline
The effect of intramuscular injection of GABA or lorazepam will be compared with buffered isotonic saline
Pain modulationDrug
Also called gamma butyric acid, glutamate, lorazepam
The effect of GABA alone or in combination with lorazepam on muscle pain produced by intramuscular injection of glutamate will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| GABA oral solution | Experimental | 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. Receives: Drug: GABA oral solution |
| Intramuscular GABA | Experimental | 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. Receives: Drug: Intramuscular GABA |
| Pain modulation | Experimental | 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. Receives: Drug: Pain modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Rating
visual analogue scale
Measured: continuously for 95 minutes
Secondary outcomes (2)
Jaw Function Tests
maximal jaw opening, maximal bite force
Measured: every 5 min for 50 minutes
Quantitative Sensory testing
Pressure detection and pain threshold, thermal detection and pain threshold
Measured: every 10 min for 90 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian E Cairns, Aalborg University
- Investigators
- Brian E Cairns, PhD DrMed, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928328
- Sponsor's protocol ID
- N-20160037
- Status last verified
- Jan 2018
- First submitted
- 6 Oct 2016
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhang Y, Wang K, Arendt-Nielsen L, Cairns BE. gamma-Aminobutyric acid (GABA) oral rinse reduces capsaicin-induced burning mouth pain sensation: An experimental quantitative sensory testing study in healthy subjects. Eur J Pain. 2018 Feb;22(2):393-401. doi: 10.1002/ejp.1128. Epub 2017 Oct 11.
PubMed 29024230
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vurdering af Perifere GABAA-receptorer Med Henblik på Lokal Smertelindring
- ClinicalTrials.gov ID
- NCT02928328
- Acronym / sponsor ID
- N-20160037
- Conditions
- Pain
- Keywords
- craniofacial pain, masticatory muscle, burning mouth syndrome, temporomandibular disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of peripheral GABAA receptor activation on pain and sensitivity in healthy human subjects has never been investigated. However, as earlier studies suggest that activation of peripheral GABAA receptors is anti-nociceptive in rats, it is important to determine if these findings can be translated into human subjects to determine if peripheral GABAA receptors are a viable target for future analgesic drug development.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GABA oral solution | Experimental | Drug: GABA oral solutionThis 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. |
| Intramuscular GABA | Experimental | Drug: Intramuscular GABAThis 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. |
| Pain modulation | Experimental | Drug: Pain modulationThis 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 20-40 years
- Free from ongoing or chronic pain
- Adequate conversational English
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GABA oral solutionAlso: gamma aminobutyric acid, lidocaine, distilled water, capsaicinOral mouth wash containing either GABA, lidocaine or distilled water will be used to decrease burning tongue pain produced by capsaicin | Drug | GABA oral solution |
| Intramuscular GABAAlso: gamma aminobutyric acid, lorazepam, buffered isotonic salineThe effect of intramuscular injection of GABA or lorazepam will be compared with buffered isotonic saline | Drug | Intramuscular GABA |
| Pain modulationAlso: gamma butyric acid, glutamate, lorazepamThe effect of GABA alone or in combination with lorazepam on muscle pain produced by intramuscular injection of glutamate will be assessed. | Drug | Pain modulation |
Primary outcome
Pain Intensity Rating
Time frame: continuously for 95 minutes
visual analogue scale
2 secondary outcomes
Jaw Function Tests
Time frame: every 5 min for 50 minutes
Quantitative Sensory testing
Time frame: every 10 min for 90 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Results publication: PubMed 29024230Zhang Y, Wang K, Arendt-Nielsen L, Cairns BE. gamma-Aminobutyric acid (GABA) oral rinse reduces capsaicin-induced burning mouth pain sensation: An experimental quantitative sensory testing study in healthy subjects. Eur J Pain. 2018 Feb;22(2):393-401. doi: 10.1002/ejp.1128. Epub 2017 Oct 11.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian E Cairns, PhD DrMed principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GABA oral solution, Intramuscular GABA and Pain modulation in people with Pain, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian E Cairns, PhD, DrMed (+45 99407521, bec@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Rating (time frame: continuously for 95 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02928328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.