Lansoprazole Versus Mosapride for Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663897
• Other study ID #: OMCP-97-007
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2008
• Last updated: October 8, 2009
• Start date: May 2008
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: Lotung Poh-Ai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Epigastric Pain Syndrome
• Functional Dyspepsia
• Gastritis
• Post Prandial Distress Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• lansoprazole
lansoprazole, 30 mg, once daily for 14 days
• mosapride
mosapride, 5 mg, thrice daily for 14 days

Locations

Country	Name	City	State
Taiwan	Lotung Poh-Ai hospital	Lotung Town, Ilan county

Sponsors (2)

Lead Sponsor	Collaborator
Lotung Poh-Ai Hospital	Tomorrow Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of dyspeptic symptoms as evaluated by validated questionnaire		After 2-week treatment of lansoprazole or mosapride	No

External Links

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