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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan
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.
Time frame: Weeks 2, 4, and 8
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