Functional DyspepsiaPhase 4NCT00663897
Lansoprazole Versus Mosapride for Functional Dyspepsia
A Phase 4 study testing lansoprazole and mosapride in people with Functional Dyspepsia and Epigastric Pain Syndrome, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Functional Dyspepsia, Epigastric Pain Syndrome, Post Prandial Distress Syndrome
- What is being tested?
- lansoprazole and mosapride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged more than 20 years old
- diagnosis of functional dyspepsia by fulfilling Rome-III criteria
- outpatient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Lansoprazole and Mosapride for Functional Dyspepsia: Focus on Difference Between Epigastric Pain Syndrome and Postprandial Distress Syndrome
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.
Read the 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.
- Being tested
- lansoprazole, mosapride
- Keywords
- functional dyspepsia, epigastric pain syndrome, postprandial distress syndrome, proton pump inhibitor, 5 HT-4 receptor agonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lansoprazoleDrug
Also called Takepron (brand name)
lansoprazole, 30 mg, once daily for 14 days
mosaprideDrug
Also called Mopride (brand name)
mosapride, 5 mg, thrice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment with lansoprazole (30 mg) once daily for 14 days Receives: Drug: lansoprazole |
| 2 | Active comparator | Treatment with mosapride (5 mg) thrice daily for 14 days Receives: Drug: mosapride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of dyspeptic symptoms as evaluated by validated questionnaire
Measured: After 2-week treatment of lansoprazole or mosapride
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lotung Poh-Ai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tomorrow Medical Foundation
- Investigators
- Yao-Chun Hsu, M.D., Principal investigator, Lotung Poh-Ai hospital, I-Lan County, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663897
- Sponsor's protocol ID
- OMCP-97-007
- Status last verified
- Oct 2009
- First submitted
- 21 Apr 2008
- Last updated
- 9 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20957498
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Lansoprazole and Mosapride for Functional Dyspepsia: Focus on Difference Between Epigastric Pain Syndrome and Postprandial Distress Syndrome
- ClinicalTrials.gov ID
- NCT00663897
- Acronym / sponsor ID
- OMCP-97-007
- Keywords
- functional dyspepsia, epigastric pain syndrome, postprandial distress syndrome, proton pump inhibitor, 5 HT-4 receptor agonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Lotung Poh-Ai HospitalUniversity, hospital or other
- Collaborators
- Tomorrow Medical Foundation
- Study start
- May 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: lansoprazoleTreatment with lansoprazole (30 mg) once daily for 14 days |
| 2 | Active comparator | Drug: mosaprideTreatment with mosapride (5 mg) thrice daily for 14 days |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged more than 20 years old
- diagnosis of functional dyspepsia by fulfilling Rome-III criteria
- outpatient
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lansoprazoleAlso: Takepron (brand name)lansoprazole, 30 mg, once daily for 14 days | Drug | 1 |
| mosaprideAlso: Mopride (brand name)mosapride, 5 mg, thrice daily for 14 days | Drug | 2 |
Primary outcome
Improvement of dyspeptic symptoms as evaluated by validated questionnaire
Time frame: After 2-week treatment of lansoprazole or mosapride
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2009.
- Derived from this study: PubMed 20957498Hsu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao-Chun Hsu, M.D. principal investigator
Lotung Poh-Ai hospital, I-Lan County, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lansoprazole and mosapride in people with Functional Dyspepsia and Epigastric Pain Syndrome, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of dyspeptic symptoms as evaluated by validated questionnaire (time frame: After 2-week treatment of lansoprazole or mosapride). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00663897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2009.