Functional Dyspepsia
Conditions
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
Interventions
DRUGMotilitone®
DRUGA-Cilin®, Clari® and Pantoline®
Sponsors
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale | 12 weeks | 5-Likert scale 1. deteriorated 2. not changed 3. moderately improved 4. markedly improved 5. symptom-free |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactJae Gyu Kim, M.D., Ph.D
Outcome results
None listed