NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000010710

Registered date:15/05/2013

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedXerostomia in Sjogrens syndrome
Date of first enrollment2013/05/15
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeAmount of increase in the unstimulated whole saliva secretion after administration 8W
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteriaPatients was given Cevimeline hydrochloride hydrate or oral pilocarpine more than one year. However,the effect was insufficient. Patients who could come to the outpatient clinic for at least 12 weeks. Patients with a salivary flow rate of not more than 10 mL for 10 min in the chewing gum test and having subjective symptoms of xerostomia. The person who gets mutual understanding. Patients with white cell and platelet count judged to be normal.
Exclude criteriaPatients 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

Contact

public contact
Name Hiroshi Iwabuchi
Address 1-10-37 Nakatomatsuri Utsunomiya-city Tochigi Japan
Telephone 81-28-622-5241
E-mail hiwabuch@tochi.hosp.go.jp
Affiliation Tochigi medical center Department of Dentistry and Oral Surgery
scientific contact
Name Hiroshi Iwabuchi
Address 1-10-37 Nakatomatsuri Utsunomiya-city Tochigi Japan
Telephone 81-28-622-5241
E-mail hiwabuch@tochi.hosp.go.jp
Affiliation Tochigi medical center Department of Dentistry and Oral Surgery