A pilot study to evaluate the use of pregabalin in the management of burning mouth syndrome
| ISRCTN | ISRCTN40332511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40332511 |
| Secondary identifying numbers | STH 13781 |
- Submission date
- 16/04/2008
- Registration date
- 21/08/2008
- Last edited
- 05/04/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Alison Loescher
Scientific
Scientific
School of Clinical Dentistry
Claremont Cresent
Sheffield
S10 2TA
United Kingdom
Study information
| Study design | Single-arm, open label, pilot study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Mrs J Parkin at j.a.parkin@sheffield.ac.uk for trial details. |
| Scientific title | |
| Study hypothesis | An open label study to evaluate the use of pregabalin in managing patients with burning mouth syndrome. |
| Ethics approval(s) | North Sheffield Research Ethics Committee. Date of approval: 19/07/2004 (ref: 04/q2308/57) |
| Condition | Burning mouth syndrome |
| Intervention | The 12-week intervention is in four stages: Stage 1: Pregabalin (oral), two weeks at 75 mg twice a day (bd) Stage 2: Either maintain 75 mg bd or increase to 150 mg bd for a further 2 weeks Stage 3: Either maintain the previous dose or increase (150 mg/ 300 mg bd) for a further 2 weeks Stage 4: Maintain the previous dose or consider increase (150 mg/ 300 mg bd) for a further 6 weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Pregabalin |
| Primary outcome measure | The following will be assessed pre-visit and at 2, 4, 6, and 12 weeks: 1. Severity of symptoms, assessed by a visual analogue scale (VAS) 2. Global impression of change |
| Secondary outcome measures | Medication side effects, recorded until 12 weeks. |
| Overall study start date | 01/06/2005 |
| Overall study end date | 31/12/2008 |
| Reason abandoned (if study stopped) | "Participant recruitment issue" |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Participant inclusion criteria | 1. Both males and females 2. Adults (over 16) 3. Diagnosis of burning mouth syndrome |
| Participant exclusion criteria | 1. Reduced renal function 2. Females who are pregnant or breast feeding 3. Patients already taking anti-convulsants or anti-depressants 4. Hereditary problems of galactose intolerance, lapp lactase deficiency and glucose-galactose malabsorption |
| Recruitment start date | 01/06/2005 |
| Recruitment end date | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Clinical Dentistry
Sheffield
S10 2TA
United Kingdom
S10 2TA
United Kingdom
Sponsor information
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research Department
3rd Floor
Pegasus House
463a Glossop Road
Sheffield
S10 2QD
England
United Kingdom
| Website | http://www.sth.nhs.uk |
|---|---|
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Industry
Educational grant from Pfizer (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
