Condition category
Signs and Symptoms
Date applied
16/04/2008
Date assigned
21/08/2008
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alison Loescher

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

STH 13781

Study information

Scientific title

Acronym

Study hypothesis

An open label study to evaluate the use of pregabalin in managing patients with burning mouth syndrome.

Ethics approval

North Sheffield Research Ethics Committee. Date of approval: 19/07/2004 (ref: 04/q2308/57)

Study design

Single-arm, open label, pilot study.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please contact Mrs J Parkin at j.a.parkin@sheffield.ac.uk for trial details.

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

Phase

Not Specified

Drug names

Pregabalin

Primary outcome measures

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 trial start date

01/06/2005

Overall trial end date

31/12/2008

Reason abandoned

"Participant recruitment issue"

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

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

United Kingdom

Trial participating centre

School of Clinical Dentistry
Sheffield
S10 2TA
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

Research Department
3rd Floor
Pegasus House
463a Glossop Road
Sheffield
S10 2QD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.sth.nhs.uk

Funders

Funder type

Industry

Funder name

Educational grant from Pfizer (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes