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

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ClinicalTrials.gov Identifier: NCT02831543
Recruitment Status : Unknown
Verified July 2016 by IlDong Pharmaceutical Co Ltd.
Recruitment status was:  Recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Motireb 5/100 mg Drug: Mosapride citrate Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

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



Primary Outcome Measures :
  1. The responder ratio of GOS(Global Overall Symptom) [ Time Frame: at the 4th week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831543


Contacts
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Contact: Min-Hee Kwon 82-2-526-3379 minhee@ildong.com
Contact: Yoan Park, Master 82-2-526-3524 yapark@ildong.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seong Nam, Kyung-gi, Korea, Republic of
Contact: Nayoung Kim, PhD, MD         
Principal Investigator: Nayoung Kim, M.D., Ph.D.         
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd
Investigators
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Principal Investigator: Nayoung Kim, M.D., Ph.D. Seoul National University Bundang Hospital

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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02831543     History of Changes
Other Study ID Numbers: ID-REMO-301
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Citric Acid
Sodium Citrate
Mosapride
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs