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.

Study Overview

• Status: Completed
• Conditions: Sjogren's Syndrome; Xerostomia
• Intervention / Treatment: Drug: Rebamipide

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Otsuka Pharmaceutical Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weeks 2, 4, and 8

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2005
• Primary Completion (Actual): January 19, 2006
• Study Completion (Actual): January 27, 2006

Study Registration Dates

• First Submitted: October 4, 2005
• First Submitted That Met QC Criteria: October 4, 2005
• First Posted (Estimate): October 5, 2005

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome; Xerostomia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Antioxidants; Rebamipide
• Other Study ID Numbers: 037-04-001; JapicCTI-050036