Exploratory Study for 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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Key information

Conditions

Xerostomia Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rebamipide

Drug

Primary outcomes

Overall Improvement Rate in Dry Mouth Symptoms

Time frame: Weeks 2, 4, and 8

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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren's Syndrome

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Oct 5, 2005
Registry last updated: Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed