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

NCT00233363 | Completed Phase 2 Results

• 2 other identifiers: 037-04-001JapicCTI-050036
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia; Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Rebamipide DRUG

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

Location

MeSH Terms

Conditions

Xerostomia; Sjogren's Syndrome

Interventions

rebamipide

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Katsuhisa Saito

  Division of New Product Evaluation and Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 5, 2005
• Study Start: April 15, 2005
• Primary Completion: January 19, 2006
• Study Completion: January 27, 2006
• Last Updated: June 4, 2021
• Results First Posted: June 4, 2021

Record last verified: 2021-05

Locations

JP (1)