Effective treatment of rebamipide on xerostomia in Sjogrens syndrome patients:a pilot study -a double-blind placebo-controlled trial-

UMIN ID: UMIN000010710

Registered date:15/05/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Xerostomia in Sjogrens syndrome
• Date of first enrollment: 2013/05/15
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Rebamipide was administered orally at 100 mg each time three times a day after meals for 8 weeks.
Placebo was administered orally three times a day after meals for 8 weeks.

Outcome(s)

• Primary Outcome: Amount of increase in the unstimulated whole saliva secretion after administration 8W

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Patients with a history of treatment or currently on treatment for facial or trigeminal neuropathy. Patients with a history of treatment or currently on treatment salivary gland disorders other than SS within 6 months before start of administration. Patients with diabetes. Patients with hypersensitivity to rebamipide. Patients now taking or who took within one month previously rebamipide. Patients taking other drug for the treatment of gastritis and gastric ulcer. Patients who have or might have upper digestive tract, hepatic or biliary disease. Patients with severe hepatic dysfunction or renal dysfunction. Women who are pregnant or who might be pregnant or lactating mothers.

Related Information

• Primary Sponsor: Tochigi medical center
• Source(s) of Monetary Support: Clinical research division of tochigi medical center