Lansoprazole Versus Mosapride for Functional Dyspepsia

This study has been completed.
Sponsor:
Collaborator:
Tomorrow Medical Foundation
Information provided by:
Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier:
NCT00663897
First received: April 21, 2008
Last updated: October 8, 2009
Last verified: October 2009
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663897

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

Additional Information:
No publications provided by Lotung Poh-Ai Hospital

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

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:
Dyspepsia
Somatoform Disorders
Gastritis
Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Disease
Pathologic Processes
Lansoprazole
Dexlansoprazole
Mosapride
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014