Rebamipide AND Sjögren Syndrome
Rebamipide for the Treatment of Xerostomia in Sjögren Syndrome
1 other identifier
interventional
55
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2012
CompletedFirst Posted
Study publicly available on registry
January 2, 2013
CompletedStudy Start
First participant enrolled
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedMarch 31, 2020
March 1, 2020
1.5 years
December 23, 2012
March 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Rebamipide
EXPERIMENTALPatients will be randomized 1:1 to receive 300mg/d (100mg x3/day) of rebamipide for 12 weeks together with their usual therapy
Placebo
PLACEBO COMPARATORPatients will be randomized 1:1 to receive 300mg/d (100mg x3/day) of placebo for 12 weeks together with their usual therapy.
Interventions
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.
Eligibility Criteria
You may qualify if:
- SS patients with dry mouth symptoms
You may not qualify if:
- Patients with dry mouth due to other conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, University of Alexandria
Alexandria, 203, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Abou-Raya, MD PhD
University of Alexandria
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 23, 2012
First Posted
January 2, 2013
Study Start
March 13, 2020
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
March 31, 2020
Record last verified: 2020-03