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The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia

Primary Purpose

Functional Dyspepsia

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Rikkunshito
Rikkunshito placebo
Sponsored by
Osaka City University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Rikkunshito, Double blind, Functional dyspepsia (FD)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    1. Bothersome postprandial fullness
    2. Early satiation
    3. Epigastric pain
    4. Epigastric burning
  • 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:

  • Confirmed ulcer (excluding scars) or malignant tumor in the upper GI
  • Suspected organic lesions in the hepato-biliary-pancreatic regions such as cholelithiasis, hepatitis, pancreatitis
  • History of upper GI resection
  • Serious complications (liver, kidney, heart, or blood disease or metabolic disease)
  • Less than a year since testing positive for H. pylori or have undergone a successful eradication therapy
  • Use of prohibited medications
  • Neuropsychiatric disorders
  • Use of or planned use of any investigational drugs
  • Unable to take drugs orally
  • History of allergic reactions to Kampo medicines
  • Pregnant or lactating women or those who are planning to conceive during the study period
  • Deemed ineligible by principal investigator or sub-investigator

Sites / Locations

  • Osaka City University Graduate School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Rikkunshito Placebo

Rikkunshito

Arm Description

Outcomes

Primary Outcome Measures

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: Significantly improved Improved Slightly improved No change Slightly worse Worse 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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
January 9, 2014
Last Updated
July 26, 2017
Sponsor
Osaka City University
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1. Study Identification

Unique Protocol Identification Number
NCT02037776
Brief Title
The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia
Official Title
Double-blind Trial With Rikkunshito Versus Placebo on Efficacy and Safety in Patients With Functional Dyspepsia: Multi-center Study (DREAM Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 3, 2014 (Actual)
Primary Completion Date
March 25, 2016 (Actual)
Study Completion Date
March 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Osaka City University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
Rikkunshito, Double blind, Functional dyspepsia (FD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rikkunshito Placebo
Arm Type
Placebo Comparator
Arm Title
Rikkunshito
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rikkunshito
Other Intervention Name(s)
Tsumura Rikkunshito
Intervention Description
- Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Rikkunshito placebo
Intervention Description
- Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
Primary Outcome Measure Information:
Title
Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
Description
Patient's Evaluation of Symptomatic Improvement by OTE is classified into the following 7 categories: Significantly improved Improved Slightly improved No change Slightly worse Worse 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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)
Description
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.
Time Frame
Baseline and Week 8
Title
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Description
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.
Time Frame
Baseline and Week 8
Title
Change From Baseline in Global Overall Symptom (GOS)
Description
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.
Time Frame
Baseline and Week 8
Title
Change From Baseline in Short-form Health Survey-8 (SF-8)
Description
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.
Time Frame
Baseline and week 8
Title
Change From Baseline in Hospital Anxiety and Depression Scale (HAD)
Description
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.
Time Frame
Baseline and week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Bothersome postprandial fullness Early satiation Epigastric pain Epigastric burning 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: Confirmed ulcer (excluding scars) or malignant tumor in the upper GI Suspected organic lesions in the hepato-biliary-pancreatic regions such as cholelithiasis, hepatitis, pancreatitis History of upper GI resection Serious complications (liver, kidney, heart, or blood disease or metabolic disease) Less than a year since testing positive for H. pylori or have undergone a successful eradication therapy Use of prohibited medications Neuropsychiatric disorders Use of or planned use of any investigational drugs Unable to take drugs orally History of allergic reactions to Kampo medicines Pregnant or lactating women or those who are planning to conceive during the study period Deemed ineligible by principal investigator or sub-investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tetsuo Arakawa
Organizational Affiliation
Osaka City University Graduate School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Osaka City University Graduate School of Medicine
City
Abeno-ku
State/Province
Osaka
ZIP/Postal Code
545-8585
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia

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