A pilot study to evaluate the use of pregabalin in the management of burning mouth syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN40332511

Enrollment

Registered

2008-08-21

Start date

2005-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning mouth syndrome Signs and Symptoms N/A

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females 2. Adults (over 16) 3. Diagnosis of burning mouth syndrome

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Medication side effects, recorded until 12 weeks.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026