Functional Dyspepsia
Conditions
Brief summary
A phase Ⅲ, multi-center, randomized, double-blinded, placebo and active comparator clinical trial to assess the efficacy and safety of combination therapy of Motireb 5/100 mg in functional dyspepsia patients.
Interventions
Sponsors
IlDong Pharmaceutical Co Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female aged 19 years or older 2. Patient with functional dyspepsia met the ROME III criteria or symptom assessment form
Exclusion criteria
1. Patient with peptic ulcer or gastroesophageal reflux disease 2. Patients with previous gastrointestinal surgery 3. Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation 4. Patients with history of gastrointestinal cancer 5. Patients with pancreatic disease (pancreatitis, pancreatic cancer, etc), biliary disease, inflammatory bowel disease, acute gastritis. 6. Patients with Zollinger-Ellison syndrome 7. Patients with irritable bowel syndrome 8. Pregnant or lactating women 9. Patients with hepatic abnormality 10. Patients with renal dysfunction or chronic kidney disease 11. Patients who are judged by the investigators to be unsuitable to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The responder ratio of GOS(Global Overall Symptom) | at the 4th week |
Countries
South Korea
Contacts
Primary ContactMin-Hee Kwon
Backup ContactYoan Park, Master
Outcome results
None listed