A Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia

Not Applicable

• Conditions: Functional Dyspepsia
• Interventions: Drug: A-Cilin®, Clari® and Pantoline®; Drug: Motilitone®

• Registration Number: NCT02162316
• Lead Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Brief Summary

This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia

Detailed Description

This is a multicenter, randomized, double-blind comparative clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia

Study Timeline

• Status Verified: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-12
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24
• Study Start: 2014-07
• Primary Completion: 2015-06
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Roman III criteria
• One or more conditions are applied: epigastric pain, epigastric burning, bothersome, postprandial fullness or early satiety
• No organic lesion
• Helicobacter pylori infection

Exclusion Criteria

• has taken prokinetics, H2 antagonists, PPIs, NSAIDs, anticholinergics, antibiotics, antidepressants, anticoagulants within a month
• had a surgery that might affect gastrointestinal motility

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
H.Pylori eradication therapy	A-Cilin®, Clari® and Pantoline®	A-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®)
Motilitone®	Motilitone®	30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin)

Primary Outcome Measures

Name	Time	Method
Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale	12 weeks	5-Likert scale; 1. deteriorated; 2. not changed; 3. moderately improved; 4. markedly improved; 5. symptom-free

Secondary Outcome Measures

Name	Time	Method
Volunteer global assessment by using 5-Likert scale	6 weeks
The improvement rate of 4 types of dyspepsia symptoms	12 weeks
Assessment of NDI-K Quality of Life	6,12 weeks
The change of each score and total score of dyspeptic symptoms	6, 12 weeks
The proportion of the patients who answered "yes for the question about symptom improvement	6, 12 weeks

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of