A Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
A Multicenter, Randomized, Double-blind Comparative Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia
1 other identifier
interventional
136
1 country
1
Brief Summary
This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2014
CompletedFirst Posted
Study publicly available on registry
June 12, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJune 24, 2014
June 1, 2014
11 months
June 11, 2014
June 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale
5-Likert scale 1. deteriorated 2. not changed 3. moderately improved 4. markedly improved 5. symptom-free
12 weeks
Secondary Outcomes (5)
Volunteer global assessment by using 5-Likert scale
6 weeks
The improvement rate of 4 types of dyspepsia symptoms
12 weeks
The change of each score and total score of dyspeptic symptoms
6, 12 weeks
Assessment of NDI-K Quality of Life
6,12 weeks
The proportion of the patients who answered "yes for the question about symptom improvement
6, 12 weeks
Study Arms (2)
H.Pylori eradication therapy
ACTIVE COMPARATORA-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®)
Motilitone®
EXPERIMENTAL30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- has taken prokinetics, H2 antagonists, PPIs, NSAIDs, anticholinergics, antibiotics, antidepressants, anticoagulants within a month
- had a surgery that might affect gastrointestinal motility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung-Ang University Hospital
Seoul, South Korea
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 11, 2014
First Posted
June 12, 2014
Study Start
July 1, 2014
Primary Completion
June 1, 2015
Study Completion
October 1, 2015
Last Updated
June 24, 2014
Record last verified: 2014-06