Xerostomia Clinical Trial
Official title:
A Randomized, Double-Blind, Vehicle-Controlled, Parallel Arm Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome
This clinical study is to determine whether daily administration of a formulation of 552-02 improves the dry mouth condition in subjects with primary Sjögren's syndrome.
The primary objective of this clinical study is to determine whether daily administration of
an oromucosal formulation of 552-02 improves the global assessment of dry mouth, as assessed
by visual analog scale (VAS), in subjects with primary Sjögren's syndrome.
The secondary objectives of this study are as follows:
- To evaluate the safety of daily administration of an oromucosal formulation of 552-02 in
subjects with primary Sjögren's syndrome.
- To evaluate whether administration of an oromucosal formulation of 552-02 improves the
subjective measurement of 6 different salivary functions, as measured using VAS, in
subjects with primary Sjögren's syndrome.
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