Exploratory Study for Dry Mouth in Patients With Sjögren’s Syndrome

This study has been completed.

Sponsored by:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00233363

Purpose

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.

Condition	Intervention	Phase
Xerostomia Sjogren's Syndrome	Drug: Rebamipide	Phase II

MedlinePlus related topics: Sjogren's Syndrome

Drug Information available for: Rebamipide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren’s Syndrome

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

overall improvement in dry mouth

Estimated Enrollment:	100
Study Start Date:	March 2005
Estimated Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233363

Locations

Japan
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director:

Katsuhisa Saito

Division of New Product Evaluation and Development

More Information

Study ID Numbers:	037-04-001, JapicCTI-050036
Study First Received:	October 4, 2005
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00233363
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Mouth Diseases
Autoimmune Diseases
Joint Diseases
Eye Diseases
Arthritis, Rheumatoid
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Rheumatic Diseases

Rebamipide
Xerostomia
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Sjogren's Syndrome
Stomatognathic Diseases
Salivary Gland Diseases

Additional relevant MeSH terms:

Disease
Antioxidants
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors

Protective Agents
Pharmacologic Actions
Pathologic Processes
Syndrome
Therapeutic Uses
Anti-Ulcer Agents

ClinicalTrials.gov processed this record on January 16, 2009