CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 104 enrolled
Drug / intervention
Rebamipidedrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Confirmed diagnosis of Sjögren's syndrome per Revised Japanese criteria (1999)
  • ✓Age 20 years or older at consent
  • ✓Presence of dry mouth (xerostomia)
  • ✓Decreased salivation documented
Key exclusion· 4
  • ✕Dry mouth clearly attributable to a cause other than Sjögren's syndrome
  • ✕Unable to undergo Saxon test (e.g., artificial teeth, implants)
  • ✕Hypersensitivity or prior adverse reaction to rebamipide
  • ✕Pregnancy, suspected pregnancy, or lactation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00233363
NCT00233363Phase 2Completed
CompareCT.gov

An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren's Syndrome

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Oct 5, 2005·Updated Jun 4, 2021

In Brief

A Phase 2 clinical trial evaluating Rebamipide for Xerostomia and Sjogren's Syndrome. Completed, enrolled 104 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsXerostomia, Sjogren's Syndrome
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 5, 2005
Enrollment StartApr 15, 2005
Primary CompletionJan 19, 2006
Study CompletionJan 27, 2006
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 20.7 years ago

Interventions

Rebamipidedrug