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

Primary Purpose

Functional Dyspepsia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Motilitone®
A-Cilin®, Clari® and Pantoline®
Sponsored by
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung-Ang University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

H.Pylori eradication therapy

Motilitone®

Arm Description

A-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®)

30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin)

Outcomes

Primary Outcome Measures

Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale
5-Likert scale deteriorated not changed moderately improved markedly improved symptom-free

Secondary Outcome Measures

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

Full Information

First Posted
June 11, 2014
Last Updated
June 23, 2014
Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02162316
Brief Title
A Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
Official Title
A Multicenter, Randomized, Double-blind Comparative Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
H.Pylori eradication therapy
Arm Type
Active Comparator
Arm Description
A-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®)
Arm Title
Motilitone®
Arm Type
Experimental
Arm Description
30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin)
Intervention Type
Drug
Intervention Name(s)
Motilitone®
Intervention Type
Drug
Intervention Name(s)
A-Cilin®, Clari® and Pantoline®
Primary Outcome Measure Information:
Title
Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale
Description
5-Likert scale deteriorated not changed moderately improved markedly improved symptom-free
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Volunteer global assessment by using 5-Likert scale
Time Frame
6 weeks
Title
The improvement rate of 4 types of dyspepsia symptoms
Time Frame
12 weeks
Title
The change of each score and total score of dyspeptic symptoms
Time Frame
6, 12 weeks
Title
Assessment of NDI-K Quality of Life
Time Frame
6,12 weeks
Title
The proportion of the patients who answered "yes for the question about symptom improvement
Time Frame
6, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Gyu Kim, M.D., Ph.D
Phone
82-2-6299-3147
Email
jgkimd@cau.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Jin Hong, M.D., Ph.D.
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gwang Ha Kim, M.D., Ph.D.
Organizational Affiliation
Busan National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang Gyun Kim, M.D., Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyun Soo Kim, M.D., Ph.D
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seong-Woo Jeon, M.D., Ph.D
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Gyu Kim, M.D., Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

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