Lansoprazole Versus Mosapride for Functional Dyspepsia

A Comparative Study of Lansoprazole and Mosapride for Functional Dyspepsia: Focus on Difference Between Epigastric Pain Syndrome and Postprandial Distress Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Epigastric Pain Syndrome; Post Prandial Distress Syndrome
• Intervention / Treatment: Drug: lansoprazole; Drug: mosapride

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.

• Study Type: Interventional
• Enrollment (Actual): 329
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Lotung Town, Ilan county, Taiwan, 26546
    • Lotung Poh-Ai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Mopride (brand name)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement of dyspeptic symptoms as evaluated by validated questionnaire	After 2-week treatment of lansoprazole or mosapride

Collaborators and Investigators

• Sponsor: Lotung Poh-Ai Hospital
• Collaborators: Tomorrow Medical Foundation
• Investigators: Principal Investigator: Yao-Chun Hsu, M.D., Lotung Poh-Ai hospital, I-Lan County, Taiwan

Publications and helpful links

General Publications

• Hsu YC, Liou JM, Yang TH, Hsu WL, Lin HJ, Wu HT, Lin JT, Wang HP, Wu MS. Proton pump inhibitor versus prokinetic therapy in patients with functional dyspepsia: is therapeutic response predicted by Rome III subgroups? J Gastroenterol. 2011 Feb;46(2):183-90. doi: 10.1007/s00535-010-0334-1. Epub 2010 Oct 19.

Helpful Links

• The homepage of ROME foundation, an non-for-profit organization dedicated to scientific research and education information of functional gastrointestinal disorders (FGIDs).

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: April 21, 2008
• First Submitted That Met QC Criteria: April 21, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Estimate): October 9, 2009
• Last Update Submitted That Met QC Criteria: October 8, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: proton pump inhibitor; functional dyspepsia; postprandial distress syndrome; epigastric pain syndrome; 5 HT-4 receptor agonist
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Signs and Symptoms, Digestive; Syndrome; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Serotonin Agents; Serotonin Receptor Agonists; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole; Mosapride
• Other Study ID Numbers: OMCP-97-007