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Lansoprazole Versus Mosapride for Functional Dyspepsia

Primary Purpose

Functional Dyspepsia, Epigastric Pain Syndrome, Post Prandial Distress Syndrome

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
lansoprazole
mosapride
Sponsored by
Lotung Poh-Ai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring functional dyspepsia, epigastric pain syndrome, postprandial distress syndrome, proton pump inhibitor, 5 HT-4 receptor agonist

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lotung Poh-Ai hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement of dyspeptic symptoms as evaluated by validated questionnaire

Secondary Outcome Measures

Full Information

First Posted
April 21, 2008
Last Updated
October 8, 2009
Sponsor
Lotung Poh-Ai Hospital
Collaborators
Tomorrow Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00663897
Brief Title
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

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lotung Poh-Ai Hospital
Collaborators
Tomorrow Medical Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
329 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Treatment with lansoprazole (30 mg) once daily for 14 days
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment with mosapride (5 mg) thrice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
lansoprazole
Other Intervention Name(s)
Takepron (brand name)
Intervention Description
lansoprazole, 30 mg, once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
mosapride
Other Intervention Name(s)
Mopride (brand name)
Intervention Description
mosapride, 5 mg, thrice daily for 14 days
Primary Outcome Measure Information:
Title
Improvement of dyspeptic symptoms as evaluated by validated questionnaire
Time Frame
After 2-week treatment of lansoprazole or mosapride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yao-Chun Hsu, M.D.
Organizational Affiliation
Lotung Poh-Ai hospital, I-Lan County, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lotung Poh-Ai hospital
City
Lotung Town, Ilan county
ZIP/Postal Code
26546
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20957498
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.
Results Reference
derived
Links:
URL
http://www.romecriteria.org/
Description
The homepage of ROME foundation, an non-for-profit organization dedicated to scientific research and education information of functional gastrointestinal disorders (FGIDs).

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Lansoprazole Versus Mosapride for Functional Dyspepsia

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