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

• Sponsor: IlDong Pharmaceutical Co Ltd (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02831543
• Collaborator: (none)
• Enrollment: 354
• Location: 1
• Arms: 3
• Duration (Months): 14
• Patients Per Site Per Month: 25.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Functional Dyspepsia	Drug: Motireb 5/100 mg; Drug: Mosapride citrate; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 354 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2016
• Anticipated Primary Completion Date: Jan 1, 2017
• Anticipated Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motireb 5/100 mg t.i.d Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d	Drug: Motireb 5/100 mg
Active Comparator: Mosapride citrate t.i.d Placebo of Motireb 5/100 mg t.i.d + Mosapride citrate t.i.d	Drug: Mosapride citrate
Placebo Comparator: Placebo t.i.d Placebo of Motireb 5/100 mg t.i.d + Placebo of Mosapride citrate t.i.d	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. The responder ratio of GOS(Global Overall Symptom) [at the 4th week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seong Nam	Kyung-gi	Korea, Republic of

Sponsors and Collaborators

• IlDong Pharmaceutical Co Ltd

Investigators

• Principal Investigator: Nayoung Kim, M.D., Ph.D., Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IlDong Pharmaceutical Co Ltd
• ClinicalTrials.gov Identifier: NCT02831543
• Other Study ID Numbers: ID-REMO-301
• First Posted: Jul 13, 2016
• Last Update Posted: Jul 13, 2016
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Dyspepsia; Mosapride

Study Results

No Results Posted as of Jul 13, 2016