Burning Mouth SyndromeBMSNCT05059418
Burning Mouth Syndrome - New Diagnostic Criteria and Treatment
A study testing Clonazepam 0.5 MG and Capsaicin Topical in people with Burning Mouth Syndrome, run by Malmö University.
Trial summary
The first part of this study is to optimize diagnostic criteria for BMS, i.e. not a clinical trial, and will not be covered in this application. The second part will compare topical treatment with clonazepam, capsaicin and placebo in a n-of-1 study design regarding effects of pain, pain-related disability… Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- Clonazepam 0.5 MG and Capsaicin Topical
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 30 Jun 2024
- 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 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary BMS according to International Classification of Orofacial Pain (ICOP) OR diagnosis of other oral mucosal pains according to ICOP
Who cannot join
- Fibromyalgia
- IBS
- Reflux
- Recent (<3 months) intraoral surgical procedure
- Ongoing medication with Clonazepam or Capsaicin
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Burning Mouth Syndrome - Optimized Diagnostic Criteria and Treatment
The first part of this study is to optimize diagnostic criteria for BMS, i.e. not a clinical trial, and will not be covered in this application.
The second part will compare topical treatment with clonazepam, capsaicin and placebo in a n-of-1 study design regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience in patients with primary BMS or other oral mucosal pain. The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months.
Read the detailed description
The clinical trial in the present study will investigate treatment effects on pain, pain-related disability, jaw function and patients' experiences by topical treatment with clonazepam or capsaicin in comparison with placebo in patients with BMS or other oral mucosal pain.
Twenty patients with primary BMS and 20 patients with other oral mucosal pain will be included. The study will comprise a n-of-1-design where each participant will be it's own control.
The study will compare topical treatment with clonazepam, capsaicin and placebo regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience. primary outcome will be pain intensity and patient experience.
The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months. After this 6 months, pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience will be assessed again.
- Conditions
- Burning Mouth Syndrome
- Being tested
- Clonazepam 0.5 MG, Capsaicin Topical, Placebo
- Keywords
- BMS, Chronic pain, Pain-related disability, Somatosensory changes, clonazepam, capsaicin, oral mucosa
- Medical subject headings
- Burning Mouth Syndrome, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clonazepam 0.5 MGDrug
Also called Iktorivil
Topical treatment of oral mucosa with lozenge pill
Capsaicin TopicalDrug
Also called Chili
Topical treatment of oral mucosa with capsaicin rinse
PlaceboOther
Also called Inget
Mouth rinse with no capsaicin
| Study group | Role | What they receive |
|---|---|---|
| Clonazepam | Active comparator | Topical treatment of oral mucosa with a 3-min lozenge tablet with clonazepam (0.5 mg), three times a day. Receives: Drug: Clonazepam 0.5 MG |
| Capsaicin | Active comparator | Topical treatment of oral mucosa with capsaicin rinsing solution (XXXX IE) for three min three times a day. Receives: Drug: Capsaicin Topical |
| Placebo | Placebo comparator | Topical treatment of oral mucosa with rinsing solution without capsaicin for three min three times a day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Overall oral mucosa pain intensity. Will be assessed using the subscale "Characteristic pain intensity" (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale
Measured: Point measurement, will be assessed immediately before start of treatment
Pain intensity
Overall oral mucosa pain intensity. Will be assessed using the subscale "Characteristic pain intensity" (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale
Measured: Point measurement, will be assessed 10 days after treatment start for each treatment period.
Pain intensity
Overall oral mucosa pain intensity. Will be assessed using the subscale "Characteristic pain intensity" (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale
Measured: Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)
Patient satisfaction
Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.
Measured: Point measurement, will be assessed immediately before start of treatment
Patient satisfaction
Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.
Measured: Point measurement, will be assessed 10 days after treatment start for each treatment period.
Patient satisfaction
Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.
Measured: Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)
Secondary outcomes (1)
Pain-related disability
Pain-related disability from oral mucosal pains. Will be assessed using the subscale "Pain-related Disability" (three numerical rating scales 0 - 10 assessing impact on the oral pain on general, social and work-related activities during the last two weeks) in the Graded Chronic Pain Scale
Measured: Point measurement, will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- N-of-1 design. Three two-week treatment arms with a one-week wash-out period in between. After that, the patient will chose their preferred treatment and continue with that treatment for 6 months (i.e. this part is not randomized or controlled).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Per Alstergren, Malmö University
- Investigators
- Per Alstergren, PhD, Prof, Principal investigator, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059418
- Sponsor's protocol ID
- BMS001
- Acronym
- BMS
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burning Mouth Syndrome - Optimized Diagnostic Criteria and Treatment
- ClinicalTrials.gov ID
- NCT05059418
- Acronym / sponsor ID
- BMS / BMS001
- Conditions
- Burning Mouth Syndrome
- Keywords
- BMS, Chronic pain, Pain-related disability, Somatosensory changes, clonazepam, capsaicin, oral mucosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 28 Sep 2021 (actual)
- 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 first part of this study is to optimize diagnostic criteria for BMS, i.e. not a clinical trial, and will not be covered in this application.
The second part will compare topical treatment with clonazepam, capsaicin and placebo in a n-of-1 study design regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience in patients with primary BMS or other oral mucosal pain. The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months.
Detailed description
The clinical trial in the present study will investigate treatment effects on pain, pain-related disability, jaw function and patients' experiences by topical treatment with clonazepam or capsaicin in comparison with placebo in patients with BMS or other oral mucosal pain.
Twenty patients with primary BMS and 20 patients with other oral mucosal pain will be included. The study will comprise a n-of-1-design where each participant will be it's own control.
The study will compare topical treatment with clonazepam, capsaicin and placebo regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience. primary outcome will be pain intensity and patient experience.
The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months. After this 6 months, pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience will be assessed again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- N-of-1 design. Three two-week treatment arms with a one-week wash-out period in between. After that, the patient will chose their preferred treatment and continue with that treatment for 6 months (i.e. this part is not randomized or controlled).
| Arm | Type | Receives |
|---|---|---|
| Clonazepam | Active comparator | Drug: Clonazepam 0.5 MGTopical treatment of oral mucosa with a 3-min lozenge tablet with clonazepam (0.5 mg), three times a day. |
| Capsaicin | Active comparator | Drug: Capsaicin TopicalTopical treatment of oral mucosa with capsaicin rinsing solution (XXXX IE) for three min three times a day. |
| Placebo | Placebo comparator | Other: PlaceboTopical treatment of oral mucosa with rinsing solution without capsaicin for three min three times a day. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of primary BMS according to International Classification of Orofacial Pain (ICOP) OR diagnosis of other oral mucosal pains according to ICOP
Key exclusion criteria (5 listed)
- Fibromyalgia
- IBS
- Reflux
- Recent (<3 months) intraoral surgical procedure
- Ongoing medication with Clonazepam or Capsaicin
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 |
|---|---|---|
| Clonazepam 0.5 MGAlso: IktorivilTopical treatment of oral mucosa with lozenge pill | Drug | Clonazepam |
| Capsaicin TopicalAlso: ChiliTopical treatment of oral mucosa with capsaicin rinse | Drug | Capsaicin |
| PlaceboAlso: IngetMouth rinse with no capsaicin | Other | Placebo |
Primary outcome
Pain intensity
Time frame: Point measurement, will be assessed immediately before start of treatment
Overall oral mucosa pain intensity. Will be assessed using the subscale "Characteristic pain intensity" (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale
Pain intensity
Time frame: Point measurement, will be assessed 10 days after treatment start for each treatment period.
Overall oral mucosa pain intensity. Will be assessed using the subscale "Characteristic pain intensity" (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale
Pain intensity
Time frame: Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)
Overall oral mucosa pain intensity. Will be assessed using the subscale "Characteristic pain intensity" (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale
Patient satisfaction
Time frame: Point measurement, will be assessed immediately before start of treatment
Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.
Patient satisfaction
Time frame: Point measurement, will be assessed 10 days after treatment start for each treatment period.
Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.
Patient satisfaction
Time frame: Point measurement, will be assessed the day after each treatment period is finished (22 days after start of each treatment)
Patient satisfaction with the treatment tested. Will be assessed using a numerical rating scale 0 - 10 where 0 = very dissatisfied and 10 = very satisfied.
1 secondary outcome
Pain-related disability
Time frame: Point measurement, will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Per Alstergren, PhD, Prof principal investigator
Malmö University
Questions about this trial
What is this clinical trial studying?
A study testing Clonazepam 0.5 MG and Capsaicin Topical in people with Burning Mouth Syndrome, run by Malmö University.
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 1 inclusion and 5 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 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Per Alstergren, PhD, Prof (+46406657000, per.alstergren@mau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Point measurement, will be assessed immediately before start of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2021.