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

This study has been completed.
ClinicalTrials.gov Identifier:
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.
October 4, 2005
October 5, 2005
May 28, 2007
March 2005
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overall improvement in dry mouth
Same as current
Complete list of historical versions of study NCT00233363 on ClinicalTrials.gov Archive Site
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Exploratory Study for Dry Mouth in Patients With Sjögren’s Syndrome
An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren’s Syndrome
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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Xerostomia
  • Sjogren's Syndrome
Drug: Rebamipide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2006
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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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Otsuka Pharmaceutical Co., Ltd.
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Study Director: Katsuhisa Saito Division of New Product Evaluation and Development
Otsuka Pharmaceutical Co., Ltd.
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP