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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233363
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : May 28, 2007
Information provided by:
Otsuka Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Xerostomia Sjogren's Syndrome Drug: Rebamipide Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren’s Syndrome
Study Start Date : March 2005
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. overall improvement in dry mouth

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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)
  2. Patients aged 20 years or older at time of consent
  3. Patients with dry mouth
  4. Patients with decreased salivation

Exclusion Criteria:

  1. Patients who have developed dry mouth clearly due to a cause other than Sjögren’s syndrome
  2. Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.)
  3. Patients who have received rebamipide within 3 months prior to obtaining informed consent
  4. Patients who are pregnant, possibly pregnant, or lactating
  5. Patients with a history of hypersensitivity to rebamipide
  6. Patients who have received any other investigational drug within 3 months prior to obtaining informed consent
  7. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00233363

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Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
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Study Director: Katsuhisa Saito Division of New Product Evaluation and Development

Layout table for additonal information Identifier: NCT00233363    
Other Study ID Numbers: 037-04-001
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: May 28, 2007
Last Verified: May 2007
Additional relevant MeSH terms:
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Mouth Diseases
Dry Eye Syndromes
Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors