Trial Outcomes & Findings for The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia (NCT NCT02037776)
NCT ID: NCT02037776
Last Updated: 2017-07-27
Results Overview
Patient's Evaluation of Symptomatic Improvement by OTE is classified into the following 7 categories: 1. Significantly improved 2. Improved 3. Slightly improved 4. No change 5. Slightly worse 6. Worse 7. Much worse 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.
COMPLETED
PHASE4
128 participants
8 weeks
2017-07-27
Participant Flow
Participant milestones
| Measure |
Rikkunshito Placebo
Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
|
Rikkunshito
Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
64
|
|
Overall Study
COMPLETED
|
56
|
60
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia
Baseline characteristics by cohort
| Measure |
Rikkunshito Placebo
n=61 Participants
Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
|
Rikkunshito
n=64 Participants
Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
Age
|
50.4 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
61 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Subtype of functional dyspepsia (FD)
Postprandial distress syndrome (PDS)
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Subtype of functional dyspepsia (FD)
Epigastric pain syndrome (EPS)
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Subtype of functional dyspepsia (FD)
Both
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Duration of FD
≥6 months to <1 year
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Duration of FD
≥1 year
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPatient's Evaluation of Symptomatic Improvement by OTE is classified into the following 7 categories: 1. Significantly improved 2. Improved 3. Slightly improved 4. No change 5. Slightly worse 6. Worse 7. Much worse 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.
Outcome measures
| Measure |
Rikkunshito Placebo
n=61 Participants
Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
|
Rikkunshito
n=64 Participants
Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
|
|---|---|---|
|
Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
4=No change
|
19 Participants
|
15 Participants
|
|
Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
1=Significantly improved
|
1 Participants
|
5 Participants
|
|
Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
2=Improved
|
13 Participants
|
18 Participants
|
|
Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
3=Slightly improved
|
25 Participants
|
26 Participants
|
|
Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
5=Slightly worse
|
3 Participants
|
0 Participants
|
|
Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
6=Worse
|
0 Participants
|
0 Participants
|
|
Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
7=Much worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8The 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.
Outcome measures
| Measure |
Rikkunshito Placebo
n=61 Participants
Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
|
Rikkunshito
n=63 Participants
Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
|
|---|---|---|
|
Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)
All symptoms
|
-4.99 units on a scale
Standard Deviation 5.92
|
-7.18 units on a scale
Standard Deviation 6.94
|
|
Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)
GERD symptoms
|
-1.69 units on a scale
Standard Deviation 2.93
|
-2.62 units on a scale
Standard Deviation 4.07
|
|
Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)
Dyspeptic symptoms
|
-3.29 units on a scale
Standard Deviation 4.25
|
-4.58 units on a scale
Standard Deviation 4.02
|
SECONDARY outcome
Timeframe: Baseline and Week 8PAGI-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.
Outcome measures
| Measure |
Rikkunshito Placebo
n=61 Participants
Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
|
Rikkunshito
n=63 Participants
Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
|
|---|---|---|
|
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Total
|
-0.30 units on a scale
Standard Deviation 0.43
|
-0.47 units on a scale
Standard Deviation 0.61
|
|
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Heartburn/Regurgitation
|
-0.23 units on a scale
Standard Deviation 0.48
|
-0.25 units on a scale
Standard Deviation 0.63
|
|
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Nausea/Vomiting
|
-0.15 units on a scale
Standard Deviation 0.75
|
-0.33 units on a scale
Standard Deviation 0.94
|
|
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Postprandial Fullness/Early satiety
|
-0.36 units on a scale
Standard Deviation 0.74
|
-0.82 units on a scale
Standard Deviation 0.98
|
|
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Bloating
|
-0.20 units on a scale
Standard Deviation 0.78
|
-0.56 units on a scale
Standard Deviation 1.00
|
|
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Upper Abdominal Pain
|
-0.56 units on a scale
Standard Deviation 1.20
|
-0.76 units on a scale
Standard Deviation 1.19
|
|
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Lower Abdominal Pain
|
-0.31 units on a scale
Standard Deviation 1.03
|
-0.13 units on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline and Week 8The 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.
Outcome measures
| Measure |
Rikkunshito Placebo
n=61 Participants
Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
|
Rikkunshito
n=64 Participants
Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
|
|---|---|---|
|
Change From Baseline in Global Overall Symptom (GOS)
|
-4.03 units on a scale
Standard Deviation 5.08
|
-6.39 units on a scale
Standard Deviation 5.22
|
SECONDARY outcome
Timeframe: Baseline and week 8The 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.
Outcome measures
| Measure |
Rikkunshito Placebo
n=61 Participants
Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
|
Rikkunshito
n=63 Participants
Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
|
|---|---|---|
|
Change From Baseline in Short-form Health Survey-8 (SF-8)
MCS
|
0.24 units on a scale
Standard Deviation 7.72
|
1.81 units on a scale
Standard Deviation 6.58
|
|
Change From Baseline in Short-form Health Survey-8 (SF-8)
PCS
|
2.68 units on a scale
Standard Deviation 5.84
|
3.87 units on a scale
Standard Deviation 7.61
|
SECONDARY outcome
Timeframe: Baseline and week 8The 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.
Outcome measures
| Measure |
Rikkunshito Placebo
n=61 Participants
Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
|
Rikkunshito
n=64 Participants
Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
|
|---|---|---|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HAD)
Overall
|
-0.34 score
Standard Deviation 4.39
|
-2.11 score
Standard Deviation 5.05
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HAD)
Depression
|
-0.05 score
Standard Deviation 2.85
|
-0.92 score
Standard Deviation 2.61
|
|
Change From Baseline in Hospital Anxiety and Depression Scale (HAD)
Anxiety
|
-0.30 score
Standard Deviation 2.26
|
-1.19 score
Standard Deviation 3.03
|
Adverse Events
Rikkunshito Placebo
Rikkunshito
Serious adverse events
| Measure |
Rikkunshito Placebo
n=63 participants at risk
Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
|
Rikkunshito
n=65 participants at risk
Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
1.6%
1/63 • Number of events 1
|
0.00%
0/65
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.6%
1/63 • Number of events 1
|
0.00%
0/65
|
Other adverse events
| Measure |
Rikkunshito Placebo
n=63 participants at risk
Rikkunshito placebo: - Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
|
Rikkunshito
n=65 participants at risk
Rikkunshito: - Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.2%
2/63
|
0.00%
0/65
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/63
|
1.5%
1/65
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/63
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/63
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
Fractures
|
1.6%
1/63
|
0.00%
0/65
|
|
Infections and infestations
Gingivitis
|
0.00%
0/63
|
1.5%
1/65
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
1/63
|
1.5%
1/65
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/63
|
1.5%
1/65
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/63
|
1.5%
1/65
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/63
|
1.5%
1/65
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/63
|
1.5%
1/65
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/63
|
1.5%
1/65
|
Additional Information
Kazunari Tominaga, M.D., Ph. D.
Osaka Medical College
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER