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Lansoprazole Versus Mosapride for Functional Dyspepsia

This study has been completed.
Tomorrow Medical Foundation
Information provided by:
Lotung Poh-Ai Hospital Identifier:
First received: April 21, 2008
Last updated: October 8, 2009
Last verified: October 2009

Functional dyspepsia is a common symptom complex with significant impact on quality of life. There is no standard treatment for functional dyspepsia but therapeutic efficacy of proton pump inhibitor (PPI) and prokinetic agent have been proved in subsets of patients. This study has two aims:

  • first is to compare the therapeutic efficacy of lansoprazole (a PPI) and mosapride (a prokinetic agent) for functional dyspepsia
  • second is to investigate whether different subgroups of functional dyspepsia (e.g., epigastric pain syndrome and postprandial distress syndrome) respond differently to PPI and prokinetic agent.

Condition Intervention Phase
Functional Dyspepsia Epigastric Pain Syndrome Post Prandial Distress Syndrome Drug: lansoprazole Drug: mosapride Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Study of Lansoprazole and Mosapride for Functional Dyspepsia: Focus on Difference Between Epigastric Pain Syndrome and Postprandial Distress Syndrome

Resource links provided by NLM:

Further study details as provided by Lotung Poh-Ai Hospital:

Primary Outcome Measures:
  • Improvement of dyspeptic symptoms as evaluated by validated questionnaire [ Time Frame: After 2-week treatment of lansoprazole or mosapride ]

Enrollment: 329
Study Start Date: May 2008
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Treatment with lansoprazole (30 mg) once daily for 14 days
Drug: lansoprazole
lansoprazole, 30 mg, once daily for 14 days
Other Name: Takepron (brand name)
Active Comparator: 2
Treatment with mosapride (5 mg) thrice daily for 14 days
Drug: mosapride
mosapride, 5 mg, thrice daily for 14 days
Other Name: Mopride (brand name)

Detailed Description:
Eligible outpatients with presentation of dyspepsia are enrolled if they fulfilled the criteria of ROME III criteria. A trained assistant helps the eligible patients to complete the ROME III standard questionaire, brief symptom rating scale (BSRS), and Maudsley Personality Inventory (MPI). The enrolled patients are then randomized into either lansoprazole or mosapride group for 14-day treatment. Before starting medication, right after completing the medication, and 1 month after the medication, the enrolled patients complete standardized severity questionnaire (Hong-Kong Index) to evaluate severity of dyspeptic symptoms. Symptom improvement is then determined.

Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • aged more than 20 years old
  • diagnosis of functional dyspepsia by fulfilling Rome-III criteria
  • outpatient

Exclusion Criteria:

  • aged less than 20 years
  • organic lesions including ulcers, tumors, bleeding, vasculopathy or esophagitis as demonstrated on upper endoscopy
  • concurrent illness with malignancy, diabetes mellitus, liver cirrhosis, renal failure or porphyria
  • diagnosis of organic disease for dyspeptic symptoms by treating physicians
  • history of abdominal surgery
  • concurrent user of aspirin and NSAID
  • history of allergy or severe side effects to lansoprazole or mosapride
  • pregnant or lactating women
  Contacts and Locations
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Please refer to this study by its identifier: NCT00663897

Lotung Poh-Ai hospital
Lotung Town, Ilan county, Taiwan, 26546
Sponsors and Collaborators
Lotung Poh-Ai Hospital
Tomorrow Medical Foundation
Principal Investigator: Yao-Chun Hsu, M.D. Lotung Poh-Ai hospital, I-Lan County, Taiwan
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hsing-Hong Chen/Superintendent, Lotung Poh-Ai hospital Identifier: NCT00663897     History of Changes
Other Study ID Numbers: OMCP-97-007
Study First Received: April 21, 2008
Last Updated: October 8, 2009

Keywords provided by Lotung Poh-Ai Hospital:
functional dyspepsia
epigastric pain syndrome
postprandial distress syndrome
proton pump inhibitor
5 HT-4 receptor agonist

Additional relevant MeSH terms:
Somatoform Disorders
Pathologic Processes
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on June 23, 2017