Clinical Trial to Assess the Efficacy and Safety of Combination Therapy of Motireb 5/100 mg in Functional Dyspepsia Patients.

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IlDong Pharmaceutical Co Ltd
• Treatments: Citric Acid; Mosapride

Criteria

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.