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The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rikkunshito Placebo | Placebo Comparator |
| |
| Rikkunshito | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rikkunshito | Drug | - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE) | Patient's Evaluation of Symptomatic Improvement by OTE is classified into the following 7 categories:
The numbers of patients at the final evaluation (i.e, the latest evaluable time point of the all patients including discontinued patients) are shown by category. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG) | The modified FSSG questionnaire is composed of 7 questions regarding GERD symptoms (Questions 1-7, scored from 0 to 4) ranging between 0-28, lower value represents a better outcome, and 7 questions regarding dyspeptic symptoms (Questions 8-14, each question scored from 0 to 4) ranging between 0-28, lower value represents a better outcome, and a total scores, ranging from 0 to 56, lower value represents a better outcome of the all questions (Questions 1-14). Each question was assigned a score based on the frequency of symptoms. The point scores of modified FSSG are calculated from changes from baseline in each score for all symptoms (sum of point scores from Questions 1-14), GERD symptoms, and dyspeptic symptoms at final evaluation. |
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Inclusion Criteria:
-Patients diagnosed with FD according to the ROME III criteria i) Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to obtaining informed consent ii) Have not received upper endoscopy within the last 6 months prior to enrollment and do not have evidence of structural/organic disease iii) Must have one or more of the following symptoms:
At least one of the FD-related symptoms on the Global Overall Symptom (GOS) scale (bothersome postprandial fullness, early satiation, epigastric pain, epigastric burning) is ≥4, whereas heartburn is ≤3.
Total score of depression-related symptoms on Hospital Anxiety and Depression Score (HAD) is ≤10.
Type of visit: Outpatient
Provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tetsuo Arakawa | Osaka City University Graduate School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka City University Graduate School of Medicine | Abeno-ku | Osaka | 545-8585 | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rikkunshito Placebo | Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks |
| FG001 | Rikkunshito | Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rikkunshito Placebo | Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks |
| BG001 | Rikkunshito | Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE) | Patient's Evaluation of Symptomatic Improvement by OTE is classified into the following 7 categories:
The numbers of patients at the final evaluation (i.e, the latest evaluable time point of the all patients including discontinued patients) are shown by category. | Posted | Count of Participants | Participants | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rikkunshito Placebo | Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingivitis | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kazunari Tominaga, M.D., Ph. D. | Osaka Medical College | +81-72-683-1221 | 8096 | in2139@osaka-med.ac.jp |
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| ID | Term |
|---|---|
| C084136 | liu-jun-zi-tang |
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| Rikkunshito placebo | Drug | - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks |
|
| Baseline and Week 8 |
| Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) | PAGI-SYM questionnaire is composed of the following 6 categories that consisted of Questions 1 to 20 (each question composed of 6 subscales, i.e., point scores from 0 to 5, lower value represents a better outcome). Subscale scores are calculated by averaging across items in each category. A total score (lower value represents a better outcome, ranging from 0 to 5) is calculated as the mean of the subscale scores. Heartburn/Regurgitation, Nausea/Vomiting, Postprandial Fullness/Early satiety, Bloating, Upper Abdominal Pain, and Lower Abdominal Pain The point scores of PAGI-SYM are calculated from changes from baseline in total score and each category score at final evaluation. | Baseline and Week 8 |
| Change From Baseline in Global Overall Symptom (GOS) | The GOS scale are calculated by a total score of a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem over 8 questions. The point scores of GOS are calculated from changes from baseline at final evaluation. | Baseline and Week 8 |
| Change From Baseline in Short-form Health Survey-8 (SF-8) | The SF-8 scores comprised of Physical component summary (PCS) scores (ranging between 5.32-70.69, higher value represents a better outcome) and Mental component summary (MCS) scores (ranging between 10.11-74.51, higher value represents a better outcome), and a total scores of PCS and MCS using a formula specified in SF-8 Scoring Algorithm. The point scores of SF-8 are calculated from changes from baseline in PCS and MCS at final evaluation. | Baseline and week 8 |
| Change From Baseline in Hospital Anxiety and Depression Scale (HAD) | The HAD is a 14-item scale with 2 subscales of depression (Question 1, 3, 5, 7, 9, 11, and 13) and anxiety (Question 2, 4, 6, 8, 10, 12, and 14). Each item on the questionnaire is scored from 0 to 3 (ranging from 0 to 21, lower value represents a better outcome). The point scores of HAD are calculated from changes from baseline in overall (sum of scores for depression and anxiety, i.e., total point score ranging from 0 to 42, lower value represents a better outcome), depression, and anxiety at final evaluation. | Baseline and week 8 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Subtype of functional dyspepsia (FD) | The subtype of FD was diagnosed according to the Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders. The Rome III criteria have divided functional dyspepsia into postprandial distress syndrome (PDS), characterized by postprandial fullness occurring after ordinary-sized meals at least several times per week and early satiation that prevents finishing a regular meal, at least several times per week, and epigastric pain syndrome (EPS), characterized by epigastric pain or burning of at least moderate severity at least once per week. | Count of Participants | Participants |
|
| Duration of FD | Count of Participants | Participants |
|
|
|
|
| Secondary | Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG) | The modified FSSG questionnaire is composed of 7 questions regarding GERD symptoms (Questions 1-7, scored from 0 to 4) ranging between 0-28, lower value represents a better outcome, and 7 questions regarding dyspeptic symptoms (Questions 8-14, each question scored from 0 to 4) ranging between 0-28, lower value represents a better outcome, and a total scores, ranging from 0 to 56, lower value represents a better outcome of the all questions (Questions 1-14). Each question was assigned a score based on the frequency of symptoms. The point scores of modified FSSG are calculated from changes from baseline in each score for all symptoms (sum of point scores from Questions 1-14), GERD symptoms, and dyspeptic symptoms at final evaluation. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
|
|
|
|
| Secondary | Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) | PAGI-SYM questionnaire is composed of the following 6 categories that consisted of Questions 1 to 20 (each question composed of 6 subscales, i.e., point scores from 0 to 5, lower value represents a better outcome). Subscale scores are calculated by averaging across items in each category. A total score (lower value represents a better outcome, ranging from 0 to 5) is calculated as the mean of the subscale scores. Heartburn/Regurgitation, Nausea/Vomiting, Postprandial Fullness/Early satiety, Bloating, Upper Abdominal Pain, and Lower Abdominal Pain The point scores of PAGI-SYM are calculated from changes from baseline in total score and each category score at final evaluation. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
|
|
|
|
| Secondary | Change From Baseline in Global Overall Symptom (GOS) | The GOS scale are calculated by a total score of a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem over 8 questions. The point scores of GOS are calculated from changes from baseline at final evaluation. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
|
|
|
|
| Secondary | Change From Baseline in Short-form Health Survey-8 (SF-8) | The SF-8 scores comprised of Physical component summary (PCS) scores (ranging between 5.32-70.69, higher value represents a better outcome) and Mental component summary (MCS) scores (ranging between 10.11-74.51, higher value represents a better outcome), and a total scores of PCS and MCS using a formula specified in SF-8 Scoring Algorithm. The point scores of SF-8 are calculated from changes from baseline in PCS and MCS at final evaluation. | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 8 |
|
|
|
|
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HAD) | The HAD is a 14-item scale with 2 subscales of depression (Question 1, 3, 5, 7, 9, 11, and 13) and anxiety (Question 2, 4, 6, 8, 10, 12, and 14). Each item on the questionnaire is scored from 0 to 3 (ranging from 0 to 21, lower value represents a better outcome). The point scores of HAD are calculated from changes from baseline in overall (sum of scores for depression and anxiety, i.e., total point score ranging from 0 to 42, lower value represents a better outcome), depression, and anxiety at final evaluation. | Posted | Mean | Standard Deviation | score | Baseline and week 8 |
|
|
|
|
| 0 |
| 63 |
| 2 |
| 63 |
| 5 |
| 63 |
| EG001 | Rikkunshito | Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks | 0 | 65 | 0 | 65 | 7 | 65 |
| Rash | Skin and subcutaneous tissue disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
|
| Abdominal pain upper | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Faeces soft | Gastrointestinal disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Fall | Injury, poisoning and procedural complications |
|
| Fractures | Injury, poisoning and procedural complications |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
| Dyspeptic symptoms |
|
| 0.089 |
| Superiority |
| Change from baseline in dyspeptic symptoms of modified FSSG | Wilcoxon (Mann-Whitney) | 0.148 | Superiority |
| Nausea/Vomiting |
|
| Postprandial Fullness/Early satiety |
|
| Bloating |
|
| Upper Abdominal Pain |
|
| Lower Abdominal Pain |
|
| 0.947 |
| Superiority |
| Change from baseline in Nausea/Vomiting of PAGI-SYM | Wilcoxon (Mann-Whitney) | 0.157 | Superiority |
| Change from baseline in Postprandial Fullness/Early satiety of PAGI-SYM | Wilcoxon (Mann-Whitney) | 0.004 | Superiority |
| Change from baseline in Bloating of PAGI-SYM | Wilcoxon (Mann-Whitney) | 0.011 | Superiority |
| Change from baseline in Upper Abdominal Pain of PAGI-SYM | Wilcoxon (Mann-Whitney) | 0.245 | Superiority |
| Change from baseline in Lower Abdominal Pain of PAGI-SYM | Wilcoxon (Mann-Whitney) | 0.387 | Superiority |
| 0.342 |
| Superiority |
| Anxiety |
|
| 0.084 |
| Superiority |
| Change from baseline in anxiety point score of HAD | Wilcoxon (Mann-Whitney) | 0.022 | Superiority |