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

IlDong Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Functional Dyspepsia

Treatments: Drug: Placebo; Drug: Motireb 5/100 mg; Drug: Mosapride citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02831543

ID-REMO-301

Details and patient eligibility

About

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.

Enrollment: 354 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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354 participants in 3 patient groups, including a placebo group

Motireb 5/100 mg t.i.d

Experimental group

Description:

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

Treatment:

Drug: Motireb 5/100 mg

Mosapride citrate t.i.d

Active Comparator group

Description:

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

Treatment:

Drug: Mosapride citrate

Placebo t.i.d

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo