20 and older, any sex, with Xerostomia or Sjogren's Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Improvement Rate in Dry Mouth SymptomsPrimary· Weeks 2, 4, and 8
At visits to the study site at two, four, and eight weeks after the start of administration, subjects self-assessed the overall change in their dry mouth symptoms in comparison with their symptoms before the start of treatment on the following four-grade scale: (1) Markedly improved (clearly better), (2) Improved (better) , (3) Unchanged (almost no difference), and (4) Aggravated (worse).
The improvement rate was calculated by defining improvement as an assessment of either (1) Markedly improved or (2) Improved.
Week 2
Group
Value
95% CI
Rebamipide
26.0
13.8 – 38.2
Placebo
20.0
8.9 – 31.1
Week 4
Group
Value
95% CI
Rebamipide
44.0
30.2 – 57.8
Placebo
27.1
14.5 – 39.7
Week 8
Group
Value
95% CI
Rebamipide
46.9
33.0 – 60.9
Placebo
39.1
25.0 – 53.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events were collected from the start of IMP administration up to 9 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd.
Last refreshed: 4 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00233363.