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

NCT02037776 | Completed Phase 4 Results DMC

• 1 other identifier: Tj43-p2-t1
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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).

Conditions

Functional Dyspepsia

Keywords

Rikkunshito; Double blind; Functional dyspepsia (FD)

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  8 weeks

Secondary Outcomes (5)

• Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)

  Baseline and Week 8

• Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)

  Baseline and Week 8

• Change From Baseline in Global Overall Symptom (GOS)

  Baseline and Week 8

• Change From Baseline in Short-form Health Survey-8 (SF-8)

  Baseline and week 8

• Change From Baseline in Hospital Anxiety and Depression Scale (HAD)

  Baseline and week 8

Study Arms (2)

Rikkunshito Placebo

PLACEBO COMPARATOR

Drug: Rikkunshito placebo

Rikkunshito

ACTIVE COMPARATOR

Drug: Rikkunshito

Interventions

Rikkunshito DRUG

\- Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks

Also known as: Tsumura Rikkunshito

Rikkunshito

Rikkunshito placebo DRUG

\- Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks

Rikkunshito Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Osaka City University: lead

Study Sites (1)

Osaka City University Graduate School of Medicine

Abeno-ku, Osaka, 545-8585, Japan

Location

MeSH Terms

Interventions

liu-jun-zi-tang

Results Point of Contact

• Title: Kazunari Tominaga, M.D., Ph. D.
• Organization: Osaka Medical College

in2139@osaka-med.ac.jp

+81-72-683-1221

Study Officials

• Tetsuo Arakawa

  Osaka City University Graduate School of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 16, 2014
• Study Start: April 3, 2014
• Primary Completion: March 25, 2016
• Study Completion: March 25, 2016
• Last Updated: July 27, 2017
• Results First Posted: July 27, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)