Clinical trial NCT02037776: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Functional Dyspepsia
Keywords: Rikkunshito
Double blind
Functional dyspepsia (FD)
Lead sponsor: Osaka City University
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 128
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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:

  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

Primary outcomes:
measure: Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)
timeFrame: Baseline and Week 8
measure: Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
timeFrame: Baseline and Week 8
measure: Change From Baseline in Global Overall Symptom (GOS)
timeFrame: Baseline and Week 8
measure: Change From Baseline in Short-form Health Survey-8 (SF-8)
timeFrame: Baseline and week 8
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HAD)
timeFrame: Baseline and week 8
Other outcomes:
Locations:
city: Abeno-ku
country: Japan
facility: Osaka City University Graduate School of Medicine
state: Osaka
Study officials:
affiliation: Osaka City University Graduate School of Medicine
name: Tetsuo Arakawa
role: STUDY_DIRECTOR
References: