Lansoprazole Versus Mosapride for Functional Dyspepsia - Full Text View

Sponsor:	Lotung Poh-Ai Hospital
Collaborator:	Tomorrow Medical Foundation
Information provided by:	Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier:	NCT00663897

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control 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:

MedlinePlus related topics: Indigestion

Drug Information available for: Lansoprazole Mosapride

U.S. FDA Resources

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
1: Experimental Treatment with lansoprazole (30 mg) once daily for 14 days	Drug: lansoprazole lansoprazole, 30 mg, once daily for 14 days
2: Active Comparator Treatment with mosapride (5 mg) thrice daily for 14 days	Drug: mosapride mosapride, 5 mg, thrice daily for 14 days

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

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:

The homepage of ROME foundation, an non-for-profit organization dedicated to scientific research and education information of functional gastrointestinal disorders (FGIDs). This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Lotung Poh-Ai hospital ( Hsing-Hong Chen/Superintendent )
Study ID Numbers:	OMCP-97-007
Study First Received:	April 21, 2008
Last Updated:	October 8, 2009
ClinicalTrials.gov Identifier:	NCT00663897 History of Changes
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:

Serotonin Agonists
Anti-Infective Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Dyspepsia
Pharmacologic Actions
Signs and Symptoms

Mosapride
Serotonin Agents
Digestive System Diseases
Stomach Diseases
Mental Disorders
Therapeutic Uses
Anti-Ulcer Agents
Lansoprazole
Somatoform Disorders
Gastroenteritis
Gastritis

ClinicalTrials.gov processed this record on March 18, 2010