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

June 23, 2014 updated by: Jae Gyu Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

A Multicenter, Randomized, Double-blind Comparative Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jae Gyu Kim, M.D., Ph.D
  • Phone Number: 82-2-6299-3147
  • Email: jgkimd@cau.ac.kr

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Chung-Ang University Hospital
        • Contact:
          • Jae Gyu Kim, M.D., Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: H.Pylori eradication therapy
A-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®)
Drug: A-Cilin®, Clari® and Pantoline®
Experimental: Motilitone®
30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin)
Drug: Motilitone®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale
Time Frame: 12 weeks

5-Likert scale

  1. deteriorated
  2. not changed
  3. moderately improved
  4. markedly improved
  5. symptom-free
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Investigators

  • Principal Investigator: Su Jin Hong, M.D., Ph.D., Soonchunhyang University Hospital
  • Principal Investigator: Gwang Ha Kim, M.D., Ph.D., Busan National University Hospital
  • Principal Investigator: Sang Gyun Kim, M.D., Ph.D, Seoul National University Hospital
  • Principal Investigator: Hyun Soo Kim, M.D., Ph.D, Chonnam National University Hospital
  • Principal Investigator: Seong-Woo Jeon, M.D., Ph.D, Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (Estimate)

June 12, 2014

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HyFu

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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