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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00233363
First Posted: October 5, 2005
Last Update Posted: May 28, 2007
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.
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

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.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00233363     History of Changes
Other Study ID Numbers: 037-04-001
JapicCTI-050036
First Submitted: October 4, 2005
First Posted: October 5, 2005
Last Update Posted: May 28, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Syndrome
Sjogren's Syndrome
Xerostomia
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rebamipide
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors