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

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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

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date June 24, 2014
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Voluteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale [ Time Frame: 12 weeks ]
5-Likert scale 0. deteriorated
  1. not changed
  2. moderately improved
  3. markedly improved
  4. symptom-free
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
  • Volunteer global assessment by using 5-Likert scale [ Time Frame: 6 weeks ]
  • The improvement rate of 4 types of dyspepsia symptoms [ Time Frame: 12 weeks ]
  • The change of each score and total score of dyspeptic symptoms [ Time Frame: 6, 12 weeks ]
  • Assessment of NDI-K Quality of Life [ Time Frame: 6,12 weeks ]
  • The proportion of the patients who answered "yes for the question about symptom improvement [ Time Frame: 6, 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • Volunteer global assessment by using 5-Likert scale [ Time Frame: 6 weeks ]
  • The improvement rate of 4 types of dyspepsia symptoms [ Time Frame: 3 weeks ]
  • The change of each score and total score of dyspeptic symptoms [ Time Frame: 6, 12 weeks ]
  • Assessment of NDI-K Quality of Life [ Time Frame: 6,12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
Official Title  ICMJE A Multicenter, Randomized, Double-blind Comparative Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Functional Dyspepsia
Intervention  ICMJE
  • Drug: Motilitone®
  • Drug: A-Cilin®, Clari® and Pantoline®
Study Arms  ICMJE
  • Active Comparator: H.Pylori eradication therapy
    A-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®)
    Intervention: Drug: A-Cilin®, Clari® and Pantoline®
  • Experimental: Motilitone®
    30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin)
    Intervention: Drug: Motilitone®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
136
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162316
Other Study ID Numbers  ICMJE HyFu
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jae Gyu Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study Sponsor  ICMJE Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP