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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN40332511 |
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Date of registration:
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21/08/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A pilot study to evaluate the use of pregabalin in the management of burning mouth syndrome
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Scientific title:
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Date of first enrolment:
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01/06/2005 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN40332511 |
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Study type:
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Interventional |
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Study design:
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Single-arm, open label, pilot study. (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Alison
Loescher |
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Address:
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School of Clinical Dentistry
Claremont Cresent
S10 2TA
Sheffield
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Both males and females
2. Adults (over 16)
3. Diagnosis of burning mouth syndrome
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Burning mouth syndrome
Signs and Symptoms
N/A
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Intervention(s)
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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
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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Medication side effects, recorded until 12 weeks.
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Secondary ID(s)
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STH 13781
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Source(s) of Monetary Support
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Educational grant from Pfizer (USA)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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