Back to resultsExploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
Primary Purpose
Xerostomia, Sjogren's Syndrome
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Rebamipide
Sponsored by
About this trial
This is an interventional treatment trial for Xerostomia
Eligibility 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
Sites / Locations
- Otsuka Pharmaceutical Co., Ltd.
Outcomes
Primary Outcome Measures
Overall Improvement Rate in Dry Mouth Symptoms
At visits to the study site at two, four, and eight weeks after the start of administration, subjects self-assessed the overall change in their dry mouth symptoms in comparison with their symptoms before the start of treatment on the following four-grade scale: (1) Markedly improved (clearly better), (2) Improved (better) , (3) Unchanged (almost no difference), and (4) Aggravated (worse).
The improvement rate was calculated by defining improvement as an assessment of either (1) Markedly improved or (2) Improved.
Secondary Outcome Measures
Full Information
NCT ID
NCT00233363
First Posted
October 4, 2005
Last Updated
May 11, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00233363
Brief Title
Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
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 Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2005 (Actual)
Primary Completion Date
January 19, 2006 (Actual)
Study Completion Date
January 27, 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia, Sjogren's Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rebamipide
Primary Outcome Measure Information:
Title
Overall Improvement Rate in Dry Mouth Symptoms
Description
At visits to the study site at two, four, and eight weeks after the start of administration, subjects self-assessed the overall change in their dry mouth symptoms in comparison with their symptoms before the start of treatment on the following four-grade scale: (1) Markedly improved (clearly better), (2) Improved (better) , (3) Unchanged (almost no difference), and (4) Aggravated (worse).
The improvement rate was calculated by defining improvement as an assessment of either (1) Markedly improved or (2) Improved.
Time Frame
Weeks 2, 4, and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
Division of New Product Evaluation and Development
Official's Role
Study Director
Facility Information:
Facility Name
Otsuka Pharmaceutical Co., Ltd.
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
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