Phase 2
N=104
Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
Xerostomia · Sjogren's Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00233363 ↗Enrolled (actual)
104
Serious AEs
1.9%
Results posted
Jun 2021
Primary outcome: Primary: Overall Improvement Rate in Dry Mouth Symptoms — 26.0; 20.0; 44.0; 27.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rebamipide (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Jan 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Improvement Rate in Dry Mouth Symptoms |
26.0; 20.0; 44.0; 27.1; 46.9; 39.1 | — |
Summary
The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.
Eligibility Criteria
Inclusion Criteria
- Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome (1999): 1998 research report on immunological intractable diseases specified by the Japanese Ministry of Health and Welfare)
- Patients aged 20 years or older at time of consent
- Patients with dry mouth
- Patients with decreased salivation
Exclusion Criteria
- Patients who have developed dry mouth clearly due to a cause other than Sjögren's syndrome
- Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.)
- Patients who have received rebamipide within 3 months prior to obtaining informed consent
- Patients who are pregnant, possibly pregnant, or lactating
- Patients with a history of hypersensitivity to rebamipide
- Patients who have received any other investigational drug within 3 months prior to obtaining informed consent
- Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
Data sourced from ClinicalTrials.gov (NCT00233363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.