Clinical trial • Phase IV • Other
CLONAZEPAM for Burning mouth syndrome
Phase IV trial of CLONAZEPAM for Burning mouth syndrome. 30 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Burning mouth syndrome
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 23-01-2024
- First CTIS Authorization Date
- 22-04-2024
Trial design
Phase IV trial across 1 site in Sweden.
- Target Sample Size
- 30
Eligibility
Recruits 30 adults.
Inclusion criteria
- {"criterion_text":"-Diagnosis BMS according to International Classification of Orofacial Pain (ICOP)"}
Exclusion criteria
- {"criterion_text":"-Se exklusionskriterier i protokollet"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Pain intensity [ Time Frame: will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start ] 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","definition_or_measurement_approach":"Overall oral mucosa pain intensity 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; assessed immediately before start of treatment and at one, two and three weeks after treatment start."}
- {"endpoint_text":"-Patient global impression of change (PGIC)","definition_or_measurement_approach":"Patient Global Impression of Change (PGIC) instrument (no further definition provided)"}
- {"endpoint_text":"-Pain related disability","definition_or_measurement_approach":"No specific measurement approach provided in the record"}
Secondary endpoints
- {"endpoint_text":"-Somatosensory changes including taste changes","definition_or_measurement_approach":"Somatosensory changes including taste changes (no further measurement detail provided)"}
- {"endpoint_text":"-Jaw function limitation using JFLS-20","definition_or_measurement_approach":"Jaw function limitation measured using the JFLS-20 instrument"}
- {"endpoint_text":"-Stress using PSS-10","definition_or_measurement_approach":"Stress measured using the PSS-10 instrument"}
- {"endpoint_text":"-Pain catastrophizing using PCS","definition_or_measurement_approach":"Pain catastrophizing measured using the PCS instrument"}
Recruitment
- Planned Sample Size
- 30
- Recruitment Window Months
- 16
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 30
Sweden
- Earliest CTIS Part Ii Submission Date
- 27-03-2024
- Latest Decision Or Authorization Date
- 22-04-2024
- Processing Time Days
- 26
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Malmoe Universitet
- Department Name
- Orofacial Pain and Jaw Function
- Principal Investigator Name
- Per Alstergren
- Principal Investigator Email
- Per.alstergren@mau.se
- Contact Person Name
- Per Alstergren
- Contact Person Email
- Per.alstergren@mau.se
Sponsor
Primary sponsor
- Full Name
- Malmoe Universitet
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- CLONAZEPAM
- Active Substance
- CLONAZEPAM
- Modality
- Small molecule
- Routes Of Administration
- Topical
- Route
- Topical
- Authorisation Status
- Approved in Sweden for systemic indications (epilepsy, seizure disorders); not approved for topical treatment in BMS
- Maximum Dose
- 1.5 mg
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