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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00233363
First received: October 4, 2005
Last updated: May 25, 2007
Last verified: May 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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:

  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
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

No publications provided

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

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

ClinicalTrials.gov processed this record on May 16, 2013