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Lansoprazole Versus Mosapride for Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT00663897
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : October 9, 2009
Sponsor:
Collaborator:
Tomorrow Medical Foundation
Information provided by:
Lotung Poh-Ai Hospital

Tracking Information
First Submitted Date  ICMJE April 21, 2008
First Posted Date  ICMJE April 22, 2008
Last Update Posted Date October 9, 2009
Study Start Date  ICMJE May 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2008)
Improvement of dyspeptic symptoms as evaluated by validated questionnaire [ Time Frame: After 2-week treatment of lansoprazole or mosapride ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lansoprazole Versus Mosapride for Functional Dyspepsia
Official Title  ICMJE A Comparative Study of Lansoprazole and Mosapride for Functional Dyspepsia: Focus on Difference Between Epigastric Pain Syndrome and Postprandial Distress Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Functional Dyspepsia
  • Epigastric Pain Syndrome
  • Post Prandial Distress Syndrome
Intervention  ICMJE
  • Drug: lansoprazole
    lansoprazole, 30 mg, once daily for 14 days
    Other Name: Takepron (brand name)
  • Drug: mosapride
    mosapride, 5 mg, thrice daily for 14 days
    Other Name: Mopride (brand name)
Study Arms  ICMJE
  • Experimental: 1
    Treatment with lansoprazole (30 mg) once daily for 14 days
    Intervention: Drug: lansoprazole
  • Active Comparator: 2
    Treatment with mosapride (5 mg) thrice daily for 14 days
    Intervention: Drug: mosapride
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2009)
329
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2008)
400
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00663897
Other Study ID Numbers  ICMJE OMCP-97-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hsing-Hong Chen/Superintendent, Lotung Poh-Ai hospital
Study Sponsor  ICMJE Lotung Poh-Ai Hospital
Collaborators  ICMJE Tomorrow Medical Foundation
Investigators  ICMJE
Principal Investigator: Yao-Chun Hsu, M.D. Lotung Poh-Ai hospital, I-Lan County, Taiwan
PRS Account Lotung Poh-Ai Hospital
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP