Rebamipide AND Sjögren Syndrome

Study Overview
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Brief Summary
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Xerostomia is a major distressing symptom in Sjőgren's syndrome(SS). Preclinical and clinical studies have demonstrated an increase in saliva volume following rebamipide administration.We thus hypothesize that rebamipide may be efficacious in the treatment of dry mouth symptoms related to Sjőgren's syndrome.We will recruit SS patients in a randomized placebo-controlled trial for 12 weeks. The main outcome measure that will concern us is patient-assessed improvement of dry mouth symptoms and increase in salivary secretion Safety and efficacy was assessed at each visit.

Detailed Description
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Xerostomia is a major distressing symptom in Sjőgren's syndrome (SS). Persistent dryness of the mouth causes oral pain, discomfort and significantly interferes with the quality of life. Rebamipide, in addition to its gastro-protective effect has displayed various anti-inflammatory actions including inhibition of neutrophilic leukocyte activation. Preclinical and clinical studies have demonstrated an increase in saliva volume following rebamipide administration. The aim of the present study is to assess efficacy of rebamipide in the treatment of dry mouth symptoms related to Sjőgren's syndrome. Methods: Fifty-five patients with American European Consensus Criteria Group (AECG)-based diagnosis of SS will participate in this randomized placebo-controlled trial. Inclusion criteria will include SS patients with dry mouth symptoms. Patients with dry mouth due to other conditions will be excluded. Patients will be randomized 1:1 to receive either 300mg/d (100mg x3/day) of rebamipide or placebo for 12 weeks together with their usual therapy. Outcome measures will include patient-assessed improvement of dry mouth symptoms and increase in salivary secretion (evaluation of unstimulated saliva; questionnaires including the visual analogue scale (VAS) for Sicca-syndrome VAS 0-100mm). Subjective and objective findings of dry mouth will be recorded at baseline, two, four, six, eight, ten and twelve weeks. Safety and efficacy will be assessed at each visit.

Official Title
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Rebamipide for the Treatment of Xerostomia in Sjögren Syndrome

Conditions
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Improving Symptoms of Dry Mouth in Sjőgren's Syndrome

Intervention / Treatment
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* Drug: Rebamipide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SS patients with dry mouth symptoms Exclusion Criteria: Patients with dry mouth due to other conditions
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rebamipide<br>Patients will be randomized 1:1 to receive 300mg/d (100mg x3/day) of rebamipide for 12 weeks together with their usual therapy | Drug: Rebamipide<br>* Patients will be randomized 1:1 to receive either 300mg/d (100mg x3/day) of rebamipide or placebo for 12 weeks together with their usual therapy.<br>* Other names: Mucosta;|
| Placebo Comparator: Placebo<br>Patients will be randomized 1:1 to receive 300mg/d (100mg x3/day) of placebo for 12 weeks together with their usual therapy. | Drug: Rebamipide<br>* Patients will be randomized 1:1 to receive either 300mg/d (100mg x3/day) of rebamipide or placebo for 12 weeks together with their usual therapy.<br>* Other names: Mucosta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of dry mouth symptoms | Improvement of dry mouth symptoms and increase in salivary secretion will be evaluated by questionnaires including the visual analogue scale (VAS) for Sicca-syndrome VAS 0-100mm. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xerostomia, rebamipide, efficacy, safety