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Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome

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Otsuka

Status and phase

Completed
Phase 2

Conditions

Xerostomia
Sjogren's Syndrome

Treatments

Drug: Rebamipide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00233363
JapicCTI-050036
037-04-001

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. 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)
  2. Patients aged 20 years or older at time of consent
  3. Patients with dry mouth
  4. Patients with decreased salivation

Exclusion criteria

  1. Patients who have developed dry mouth clearly due to a cause other than Sjögren's syndrome
  2. Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.)
  3. Patients who have received rebamipide within 3 months prior to obtaining informed consent
  4. Patients who are pregnant, possibly pregnant, or lactating
  5. Patients with a history of hypersensitivity to rebamipide
  6. Patients who have received any other investigational drug within 3 months prior to obtaining informed consent
  7. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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