Sjogren's Syndrome, Xerostomia
Conditions
Brief 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.
Interventions
DRUGRebamipide
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rebamipide A rebamipide 100 mg tablet was administered orally three times a day for eight weeks. | 50 |
| Placebo A placebo tablet was administered orally three times a day for eight weeks. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Aggravation of complication | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Rebamipide | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 17 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 33 Participants | 66 Participants |
| Region of Enrollment Japan | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Female | 49 Participants | 48 Participants | 97 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 51 |
| other Total, other adverse events | 31 / 53 | 34 / 51 |
| serious Total, serious adverse events | 1 / 53 | 1 / 51 |
Outcome results
Primary
Overall Improvement Rate in Dry Mouth Symptoms
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.
Time frame: Weeks 2, 4, and 8
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rebamipide | Overall Improvement Rate in Dry Mouth Symptoms | Week 2 | 26.0 percentage of participants |
| Rebamipide | Overall Improvement Rate in Dry Mouth Symptoms | Week 4 | 44.0 percentage of participants |
| Rebamipide | Overall Improvement Rate in Dry Mouth Symptoms | Week 8 | 46.9 percentage of participants |
| Placebo | Overall Improvement Rate in Dry Mouth Symptoms | Week 2 | 20.0 percentage of participants |
| Placebo | Overall Improvement Rate in Dry Mouth Symptoms | Week 4 | 27.1 percentage of participants |
| Placebo | Overall Improvement Rate in Dry Mouth Symptoms | Week 8 | 39.1 percentage of participants |