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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162316
Recruitment Status : Unknown
Verified June 2014 by Jae Gyu Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : June 12, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Jae Gyu Kim, 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

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Motilitone® Drug: A-Cilin®, Clari® and Pantoline® Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind Comparative Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
Study Start Date : July 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

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®



Primary Outcome Measures :
  1. 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


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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162316


Contacts
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Contact: Jae Gyu Kim, M.D., Ph.D 82-2-6299-3147 jgkimd@cau.ac.kr

Locations
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Korea, Republic of
Chung-Ang University Hospital
Seoul, Korea, Republic of
Contact: Jae Gyu Kim, M.D., Ph.D         
Sponsors and Collaborators
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Investigators
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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
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Responsible Party: Jae Gyu Kim, Professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
ClinicalTrials.gov Identifier: NCT02162316    
Other Study ID Numbers: HyFu
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive