Trial · NCT00233363
Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
NCT00233363, Phase 2, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2021-06-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome. Trials, record NCT00233363. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00233363
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Study for Dry Mouth in Patients With Sjögren's Syndrome
- NCT number
- NCT00233363
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 104 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Xerostomia, Sjogren's Syndrome
- Interventions
- Rebamipide
- First posted
- 2005-10-05
- Last updated
- 2021-06-04
- Results first posted
- 2021-06-04
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Improvement Rate in Dry Mouth Symptoms | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Improvement Rate in Dry Mouth Symptoms | Weeks 2, 4, and 8 | The Efficacy Analysis Set comprised subjects in the Full Analysis Set (subjects received IMP at least once) excluding ineligible subjects and subjects with protocol deviations as described below:~1. Subjects violating the rules on concomitant therapy~2. Subjects with poor treatment compliance (\<80% of the prescribed dose at time of treatment discontinuation/completion)~3. Subjects with missing data on the primary endpoint at all time points | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Improvement Rate in Dry Mouth Symptoms | Rebamipide | Week 2 | 26.0 | 95% Confidence Interval 13.8 to 38.2 | percentage of participants |
| Overall Improvement Rate in Dry Mouth Symptoms | Placebo | Week 2 | 20.0 | 95% Confidence Interval 8.9 to 31.1 | percentage of participants |
| Overall Improvement Rate in Dry Mouth Symptoms | Rebamipide | Week 4 | 44.0 | 95% Confidence Interval 30.2 to 57.8 | percentage of participants |
| Overall Improvement Rate in Dry Mouth Symptoms | Placebo | Week 4 | 27.1 | 95% Confidence Interval 14.5 to 39.7 | percentage of participants |
| Overall Improvement Rate in Dry Mouth Symptoms | Rebamipide | Week 8 | 46.9 | 95% Confidence Interval 33.0 to 60.9 | percentage of participants |
| Overall Improvement Rate in Dry Mouth Symptoms | Placebo | Week 8 | 39.1 | 95% Confidence Interval 25.0 to 53.2 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rebamipide | 53 | |
| Overall Study | STARTED | Placebo | 51 | |
| Overall Study | COMPLETED | Rebamipide | 50 | |
| Overall Study | COMPLETED | Placebo | 46 | |
| Overall Study | NOT COMPLETED | Rebamipide | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events162
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blepharitis | Eye disorders | Rebamipide | 0 | 53 | |
| other | Blepharitis | Eye disorders | Placebo | 1 | 51 | |
| other | Blepharospasm | Eye disorders | Rebamipide | 0 | 53 | |
| other | Blepharospasm | Eye disorders | Placebo | 1 | 51 | |
| other | Conjunctivitis | Eye disorders | Rebamipide | 0 | 53 | |
| other | Conjunctivitis | Eye disorders | Placebo | 1 | 51 | |
| other | Conjunctivitis allergic | Eye disorders | Rebamipide | 0 | 53 | |
| other | Conjunctivitis allergic | Eye disorders | Placebo | 1 | 51 | |
| other | Ocular hyperaemia | Eye disorders | Rebamipide | 1 | 53 | |
| other | Ocular hyperaemia | Eye disorders | Placebo | 0 | 51 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rebamipide | 0 | 53 |
| Total, all-cause mortality | Placebo | 0 | 51 |
| Total, other adverse events | Rebamipide | 31 | 53 |
| Total, other adverse events | Placebo | 34 | 51 |
| Total, serious adverse events | Rebamipide | 1 | 53 |
| Total, serious adverse events | Placebo | 1 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rebamipide vs Placebo: deaths from any cause | Trial comparisons |
| Rebamipide vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00233363
GET https://conductscience.org/api/trials/v1/NCT00233363/events?page=2