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

Functional Dyspepsia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02831543
• Other study ID #: ID-REMO-301
• Status: Recruiting
• Phase: Phase 3
• First received: July 11, 2016
• Last updated: July 11, 2016
• Start date: April 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2016
• Source: IlDong Pharmaceutical Co Ltd
• Contact: Min-Hee Kwon
• Phone: 82-2-526-3379
• Email: minhee[@]ildong.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Drug:
• Motireb 5/100 mg

• Mosapride citrate

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seong Nam	Kyung-gi

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The responder ratio of GOS(Global Overall Symptom)		at the 4th week	No