Status:
COMPLETED
Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Xerostomia
Sjogren's Syndrome
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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
- 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
- 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
Key Trial Info
Start Date :
April 15 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2006
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00233363
Start Date
April 15 2005
End Date
January 27 2006
Last Update
June 4 2021
Active Locations (1)
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1
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan