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

Phase 3

• Conditions: Functional Dyspepsia
• Interventions: Drug: Mosapride citrate; Drug: Motireb 5/100 mg; Drug: Placebo

• Registration Number: NCT02831543
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Status Verified: 2016-07
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Last Update Submitted: 2016-07-11
• Study First Posted: 2016-07-13
• Last Update Posted: 2016-07-13
• Primary Completion: 2017-01
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 354

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mosapride citrate t.i.d	Mosapride citrate	Placebo of Motireb 5/100 mg t.i.d + Mosapride citrate t.i.d
Motireb 5/100 mg t.i.d	Motireb 5/100 mg	Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d
Placebo t.i.d	Placebo	Placebo of Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d

Primary Outcome Measures

Name	Time	Method
The responder ratio of GOS(Global Overall Symptom)	at the 4th week

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seong Nam, Kyung-gi, Korea, Republic of