Functional DyspepsiaPhase 4NCT02037776
The Efficacy and Safety Study of Rikkunshito in Patients With Functional Dyspepsia
A Phase 4 study testing Rikkunshito in people with Functional Dyspepsia, run by Osaka City University at 1 site in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Rikkunshito
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteJapan
- Study dates
- 3 Apr 2014to 25 Mar 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Osaka City University Graduate School of Medicine
Abeno-ku, Osaka, 545-8585
About this study
Official title: Double-blind Trial With Rikkunshito Versus Placebo on Efficacy and Safety in Patients With Functional Dyspepsia: Multi-center Study (DREAM Study)
The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).
- Conditions
- Functional Dyspepsia
- Being tested
- Rikkunshito, Rikkunshito placebo
- Keywords
- Rikkunshito, Double blind, Functional dyspepsia (FD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RikkunshitoDrug
Also called Tsumura Rikkunshito
- Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
Rikkunshito placeboDrug
- Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rikkunshito Placebo | Placebo comparator | Not described Receives: Drug: Rikkunshito placebo |
| Rikkunshito | Active comparator | Not described Receives: Drug: Rikkunshito |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study start3 Apr 2014
- Primary completion25 Mar 2016
- Study completion25 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazunari Tominaga, Osaka Medical College
- Investigators
- Tetsuo Arakawa, Study director, Osaka City University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037776
- Sponsor's protocol ID
- Tj43-p2-t1
- Status last verified
- Jul 2017
- First submitted
- 9 Jan 2014
- Last updated
- 27 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Trial With Rikkunshito Versus Placebo on Efficacy and Safety in Patients With Functional Dyspepsia: Multi-center Study (DREAM Study)
- ClinicalTrials.gov ID
- NCT02037776
- Acronym / sponsor ID
- Tj43-p2-t1
- Conditions
- Functional Dyspepsia
- Keywords
- Rikkunshito, Double blind, Functional dyspepsia (FD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Osaka City UniversityUniversity, hospital or other
- Study start
- 3 Apr 2014 (actual)
- Primary completion
- 25 Mar 2016 (actual)
- Study completion
- 25 Mar 2016 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Posted 27 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of Rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia (FD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rikkunshito Placebo | Placebo comparator | Drug: Rikkunshito placebo |
| Rikkunshito | Active comparator | Drug: Rikkunshito |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- -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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RikkunshitoAlso: Tsumura Rikkunshito- Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks | Drug | Rikkunshito |
| Rikkunshito placebo- Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks | Drug | Rikkunshito Placebo |
Primary outcome
Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
Time frame: 8 weeks
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.
5 secondary outcomes
Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)
Time frame: Baseline and Week 8
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Time frame: Baseline and Week 8
Change From Baseline in Global Overall Symptom (GOS)
Time frame: Baseline and Week 8
Change From Baseline in Short-form Health Survey-8 (SF-8)
Time frame: Baseline and week 8
Change From Baseline in Hospital Anxiety and Depression Scale (HAD)
Time frame: Baseline and week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetsuo Arakawa study director
Osaka City University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rikkunshito in people with Functional Dyspepsia, run by Osaka City University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.