Rebamipide AND Sjögren Syndrome

Improving Symptoms of Dry Mouth in Sjogren's Syndrome Clinical Trial

Official title:

Rebamipide for the Treatment of Xerostomia in Sjögren Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01759108
• Other study ID #: 116619963
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: September 2021

Study information

• Verified date: March 2020
• Source: University of Alexandria
• Contact: Anna Abou-Raya, MD PhD
• Phone: 5924601
• Email: annaaraya[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• SS patients with dry mouth symptoms

Exclusion Criteria:

• Patients with dry mouth due to other conditions

Related Conditions & MeSH terms

• Improving Symptoms of Dry Mouth in Sjogren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Rebamipide
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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, University of Alexandria	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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