Clinical trial NCT00663897: Lansoprazole Versus Mosapride for Functional Dyspepsia
Official title: A Comparative Study of Lansoprazole and Mosapride for Functional Dyspepsia: Focus on Difference Between Epigastric Pain Syndrome and Postprandial Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Functional Dyspepsia
Epigastric Pain Syndrome
Post Prandial Distress Syndrome
Keywords: functional dyspepsia
epigastric pain syndrome
postprandial distress syndrome
proton pump inhibitor
5 HT-4 receptor agonist
Lead sponsor: Lotung Poh-Ai Hospital
Sponsor class: OTHER
Collaborators: name: Tomorrow Medical Foundation
First posted: 2008-04-22
Enrollment: 329
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Improvement of dyspeptic symptoms as evaluated by validated questionnaire
timeFrame: After 2-week treatment of lansoprazole or mosapride
Secondary outcomes:
Other outcomes:
Locations:
city: Lotung Town, Ilan county
country: Taiwan
facility: Lotung Poh-Ai hospital
Study officials:
affiliation: Lotung Poh-Ai hospital, I-Lan County, Taiwan
name: Yao-Chun Hsu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.