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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000012808
Receipt No. R000014957
Scientific Title Double-blind Trial with Rikkunshito versus Placebo on Efficacy and Safety in Patients with Functional Dyspepsia :Multi-center Study
Date of disclosure of the study information 2014/03/31
Last modified on 2017/02/17

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Basic information
Public title Double-blind Trial with Rikkunshito versus Placebo on Efficacy and Safety
in Patients with Functional Dyspepsia :Multi-center Study
Acronym DREAM Study
Scientific Title Double-blind Trial with Rikkunshito versus Placebo on Efficacy and Safety
in Patients with Functional Dyspepsia :Multi-center Study
Scientific Title:Acronym DREAM Study
Region
Japan

Condition
Condition Functional Dyspepsia
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to assess the efficacy and safety of rikkunshito compared to placebo in Japanese subjects with Functional Dyspepsia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Global assessment of overall treatment efficacy (OTE). At 4 and 8-week after treatment
Key secondary outcomes Global overall symptom (GOS)
Modified frequency scale for the symptoms of GERD (Modified FSSG)
The patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM)
Hospital anxiety and depression scale (HADS)
Short-form health survy-8 (SF-8)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rikkunshito
Interventions/Control_2 Rikkunshito placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients diagnosed with FD according
to the Rome III criteria
1) Criteria fulfilled for the last 3
months with symptom onset at least
6 months prior to diagnosis
2) Have not received upper endoscopy
within the last 6 months prior to
enrollment and do not have
evidence of structural/organic
disease
3) Must have one or more of the
following symptoms:
a) Bothersome postprandial fullness
b) Early satiation
c) Epigastric pain
d) Epigastric burning
2.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.
3.Total score of depression-related symptoms on Hospital Anxiety and Depression Score (HAD) is <10.
4.Age: Aged 20 and over
5.No criteria on sex.
6.Type of visit: Outpatient.
7.Provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study.
Key exclusion criteria 1.Confirmed ulcer (excluding scars) or malignant tumor in the upper GI.
2.Suspected organic lesions in the hepato-biliary-pancreatic regions such as cholelithiasis, hepatitis, pancreatitis.
3.History of upper GI resection.
4.Serious complications (liver, kidney, heart, or blood disease or metabolic disease).
5.Less than a year since testing positive for H. pylori or have undergone asuccessful eradication therapy.
6.Use of prohibited medications.
7.Neuropsychiatric disorders.
8.Use of or planned use of another
investigational drug.
9.Unable to take drugs orally.
10.History of allergic reactions to Kampo medicines.
11.Pregnant or lactating women or those who are planning to conceive during the study period.
12.Deemed ineligible by principal investigator or sub-investigator
Target sample size 460

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Arakawa
Organization Osaka City University (President)
Division name Department of Gastroenterology
Zip code
Address 3-3-138, Sugimoto, Sumiyoshi-ku, Osaka
TEL 06-8805-2000
Email arakawa@ad.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunari Tominaga
Organization Osaka Medical College
Division name Department of Gastroenterology
Zip code
Address 2-7, Daigaku-machi, Takatsuki-shi, Osaka
TEL 072-683-1221
Homepage URL
Email in2139@osaka-med.ac.jp

Sponsor
Institute DREAM study group
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan INC
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02037776
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学病院(北海道)  岩手医科大学病院(岩手県)
群馬大学医学部附属病院(群馬県) 順天堂大学医学部附属順天堂医院(東京都)
杏林大学医学部付属病院(東京都) 千葉大学医学部附属病院(千葉県)
日本医科大学付属病院(東京都)  大阪市立大学医学部附属病院(大阪府)
浜松医科大学医学部附属病院(静岡県) 兵庫医科大学病院(兵庫県)
大阪医科大学附属病院(大阪府)  島根大学医学部附属病院(島根県)
川崎医科大学附属病院(岡山県)  熊本大学医学部附属病院(熊本県)
佐賀大学医学部附属病院(佐賀県) 大分大学医学部附属病院(大分県)

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results In this study, 128 patients were included in the safety analysis set and 125 were included in the full analysis set (FAS). As for demographic characteristics in the FAS, there were more women (89 patients) than men (36 patients); mean age was 50.4; mean BMI was 21.2 kg/m2; 82 patients had duration of FD >1 year. Regarding a subtype of FD, 49 patients had a PDS subtype, 42 had an EPS, and 34 had overlapping PDS-EPS. A total of 114 patients had no overlapping with IBS.

In the analysis of the score distribution of 7 categories in OTE at the final data (i.e., the latest evaluable time point of the all patients including discontinued patients) in the FAS, a primary endpoint of this study, the patients in Rikkunshito group ranged between score 1 and 4, those in Rikkunshito placebo group (including those worsened) ranged between score 1 and 5, and statistically significant differences were observed (p=0.038).
In the secondary endpoints, changes from baseline at the final data were statistically significant differences between groups in a total scores of Modified FSSG, GOS score, subscores of Postprandial Fullness/Early satiety and Bloating in PAGI-SYM, as well as overall score and Anxiety subscore of HAD. No statistical differences were observed in either PCS or MCS score of SF-8.

In the safety analysis set, the incidence of AEs was 10.8% (7/65 patients) in Rikkunshito group and 11.1% (7/63) in Rikkunshito placebo group. The most common AEs reported by SOC were Gastrointestinal disorders in the both groups (4 patients in Rikkunshito group, 3 in Rikkunshito placebo group). The incidence of ADRs was 4.6% (constipation, diarrhoea, and faeces soft, 1 patient each) in Rikkunshito group and 1.6% (rush, 1 patient) in Rikkunshito placebo group. SAEs were reported from 2 patients in Rikkunshito placebo group (cervix carcinoma, rush). No death occurred in this study.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 03 Day
Last follow-up date
2016 Year 03 Month 25 Day
Date of closure to data entry
2016 Year 07 Month 11 Day
Date trial data considered complete
2016 Year 07 Month 27 Day
Date analysis concluded
2016 Year 12 Month 09 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 09 Day
Last modified on
2017 Year 02 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014957

Research Plan
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Research case data specifications
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Research case data
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