Lansoprazole Versus Mosapride for Functional Dyspepsia

NCT00663897 | Completed Phase 4 DMC

• 1 other identifier: OMCP-97-007
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Improvement of dyspeptic symptoms as evaluated by validated questionnaire

  After 2-week treatment of lansoprazole or mosapride

Study Arms (2)

1

EXPERIMENTAL

Treatment with lansoprazole (30 mg) once daily for 14 days

Drug: lansoprazole

2

ACTIVE COMPARATOR

Treatment with mosapride (5 mg) thrice daily for 14 days

Drug: mosapride

Interventions

lansoprazole DRUG

lansoprazole, 30 mg, once daily for 14 days

Also known as: Takepron (brand name)

1

mosapride DRUG

mosapride, 5 mg, thrice daily for 14 days

Also known as: Mopride (brand name)

2

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged more than 20 years old
• diagnosis of functional dyspepsia by fulfilling Rome-III criteria
• outpatient

You may not qualify if:

• 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

Sponsors & Collaborators

• Lotung Poh-Ai Hospital: lead
• Tomorrow Medical Foundation: collaborator

Study Sites (1)

Lotung Poh-Ai hospital

Lotung Town, Ilan County, 26546, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 20957498 DERIVED

Related Links

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

MeSH Terms

Interventions

Lansoprazole; mosapride

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yao-Chun Hsu, M.D.

  Lotung Poh-Ai hospital, I-Lan County, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 22, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 9, 2009

Record last verified: 2009-10

Locations

TW (1)