Lansoprazole Versus Mosapride for Functional Dyspepsia
This study has been completed.
Sponsor:
Lotung Poh-Ai Hospital
Collaborator:
Tomorrow Medical Foundation
Information provided by:
Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier:
NCT00663897
First received: April 21, 2008
Last updated: October 8, 2009
Last verified: October 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Functional Dyspepsia Epigastric Pain Syndrome Post Prandial Distress Syndrome |
Drug: lansoprazole Drug: mosapride |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Comparative Study of Lansoprazole and Mosapride for Functional Dyspepsia: Focus on Difference Between Epigastric Pain Syndrome and Postprandial Distress Syndrome |
Resource links provided by NLM:
Further study details as provided by Lotung Poh-Ai Hospital:
Primary Outcome Measures:
- Improvement of dyspeptic symptoms as evaluated by validated questionnaire [ Time Frame: After 2-week treatment of lansoprazole or mosapride ] [ Designated as safety issue: No ]
| Enrollment: | 329 |
| Study Start Date: | May 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Treatment with lansoprazole (30 mg) once daily for 14 days
|
Drug: lansoprazole
lansoprazole, 30 mg, once daily for 14 days
Other Name: Takepron (brand name)
|
|
Active Comparator: 2
Treatment with mosapride (5 mg) thrice daily for 14 days
|
Drug: mosapride
mosapride, 5 mg, thrice daily for 14 days
Other Name: Mopride (brand name)
|
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| Ages Eligible for Study: | 20 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663897
Locations
| Taiwan | |
| Lotung Poh-Ai hospital | |
| Lotung Town, Ilan county, Taiwan, 26546 | |
Sponsors and Collaborators
Lotung Poh-Ai Hospital
Tomorrow Medical Foundation
Investigators
| Principal Investigator: | Yao-Chun Hsu, M.D. | Lotung Poh-Ai hospital, I-Lan County, Taiwan |
More Information
Additional Information:
No publications provided by Lotung Poh-Ai Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hsing-Hong Chen/Superintendent, Lotung Poh-Ai hospital |
| ClinicalTrials.gov Identifier: | NCT00663897 History of Changes |
| Other Study ID Numbers: | OMCP-97-007 |
| Study First Received: | April 21, 2008 |
| Last Updated: | October 8, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Lotung Poh-Ai Hospital:
|
functional dyspepsia epigastric pain syndrome postprandial distress syndrome proton pump inhibitor 5 HT-4 receptor agonist |
Additional relevant MeSH terms:
|
Dyspepsia Gastritis Somatoform Disorders Signs and Symptoms, Digestive Signs and Symptoms Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Stomach Diseases Mental Disorders Lansoprazole Mosapride |
Proton Pump Inhibitors Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013