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
Protocol serial number	STH 13781
Sponsor	Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Funder	Educational grant from Pfizer (USA)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Alison Loescher
Scientific

School of Clinical Dentistry
Claremont Cresent
Sheffield
S10 2TA
United Kingdom

Primary study design	Interventional
Study design	Single-arm, open label, pilot study.
Secondary study design	Non randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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)
Health condition(s) or problem(s) studied	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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Pregabalin
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Medication side effects, recorded until 12 weeks.
Completion date	31/12/2008
Reason abandoned (if study stopped)	"Participant recruitment issue"

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. Both males and females 2. Adults (over 16) 3. Diagnosis of burning mouth syndrome
Key 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
Date of first enrolment	01/06/2005
Date of final enrolment	31/12/2008

School of Clinical Dentistry

Sheffield
S10 2TA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes