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Lansoprazole Versus Mosapride for Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT00663897
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : October 9, 2009
Tomorrow Medical Foundation
Information provided by:
Lotung Poh-Ai Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Functional Dyspepsia Epigastric Pain Syndrome Post Prandial Distress Syndrome Drug: lansoprazole Drug: mosapride Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
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

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): NCT00663897

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Lotung Poh-Ai hospital
Lotung Town, Ilan county, Taiwan, 26546
Sponsors and Collaborators
Lotung Poh-Ai Hospital
Tomorrow Medical Foundation
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Principal Investigator: Yao-Chun Hsu, M.D. Lotung Poh-Ai hospital, I-Lan County, Taiwan
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hsing-Hong Chen/Superintendent, Lotung Poh-Ai hospital
ClinicalTrials.gov Identifier: NCT00663897    
Other Study ID Numbers: OMCP-97-007
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: October 9, 2009
Last Verified: October 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:
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Pathologic Processes
Signs and Symptoms, Digestive
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