Gastroesophageal Reflux DiseasePhase 4NCT00729339
Role of Mosapride in Patients With Gastroesophageal Reflux Disease
A Phase 4 study of Gastroesophageal Reflux Disease, run by Lotung Poh-Ai Hospital at 1 site in Taiwan.
Trial summary
Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators' eating style is closing to Western world. Proton pump is the main drug for patients with GERD in the past two decades. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2008to May 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 90 years old
- Outpatients
- Characteristic GERD symptoms: acid regurgitation, heart burn, or belching
- Erosive esophagitis on upper digestive endoscopy, based on Los Angeles classification
Who cannot join
- History of allergy to lansoprazole or mosapride
- Pregnant or lactating women
- Uremia
- Decompensated liver disease
- Age under 18 and over 90 years-old
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators' eating style is closing to Western world.
Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of prokinetic agent in the management of GERD.
Read the detailed description
This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one month and two months of the study.
This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching, dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month. Another fifty patients receive lansoprazole 30 mg once plus placebo tid daily in the first month; and lansoprazole 30 mg once plus mosapride 5 mg tid daily in the second month.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- mosapride for the first month and placebo for the 2nd month, placebo for the first and mosapride for the second month
- Keywords
- Gastroesophageal reflux disease, Mosapride, Lansoprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mosapride for the first month and placebo for the 2nd monthDrug
lansoprazole 30 mg once per day for 2 months mosapride 5 mg thrice per day, for the first month placebo thrice per day, for the second month
placebo for the first and mosapride for the second monthDrug
lansoprazole 30 mg once per day for 2 months placebo thrice per day, for the first month mosapride 5 mg thrice per day, for the second month
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | lansoprazole plus mosapride for the first month, and followed by lansoprazole plus placebo for the second month Receives: Drug: mosapride for the first month and placebo for the 2nd month |
| 2 | Active comparator | lansoprazole plus placebo for the first month, and lansoprazole plus mosapride for the second month Receives: Drug: placebo for the first and mosapride for the second month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG)
Measured: before enrollment, one month after treatment, two months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lotung Poh-Ai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tomorrow Medical Foundation
- Investigators
- Hwai-Jeng Lin, M.D., Principal investigator, Lotung Poh-Ai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729339
- Sponsor's protocol ID
- OMCP-97-011
- Status last verified
- May 2009
- First submitted
- 31 Jul 2008
- Last updated
- 13 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mosapride in Patients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT00729339
- Acronym / sponsor ID
- OMCP-97-011
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal reflux disease, Mosapride, Lansoprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Lotung Poh-Ai HospitalUniversity, hospital or other
- Collaborators
- Tomorrow Medical Foundation
- Study start
- Jun 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Aug 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.
Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators' eating style is closing to Western world.
Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of prokinetic agent in the management of GERD.
Detailed description
This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one month and two months of the study.
This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching, dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month. Another fifty patients receive lansoprazole 30 mg once plus placebo tid daily in the first month; and lansoprazole 30 mg once plus mosapride 5 mg tid daily in the second month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: mosapride for the first month and placebo for the 2nd monthlansoprazole plus mosapride for the first month, and followed by lansoprazole plus placebo for the second month |
| 2 | Active comparator | Drug: placebo for the first and mosapride for the second monthlansoprazole plus placebo for the first month, and lansoprazole plus mosapride for the second month |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 90 years old
- Outpatients
- Characteristic GERD symptoms: acid regurgitation, heart burn, or belching
- Erosive esophagitis on upper digestive endoscopy, based on Los Angeles classification
Key exclusion criteria (6 listed)
- History of allergy to lansoprazole or mosapride
- Pregnant or lactating women
- Uremia
- Decompensated liver disease
- Age under 18 and over 90 years-old
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 |
|---|---|---|
| mosapride for the first month and placebo for the 2nd monthlansoprazole 30 mg once per day for 2 months mosapride 5 mg thrice per day, for the first month placebo thrice per day, for the second month | Drug | 1 |
| placebo for the first and mosapride for the second monthlansoprazole 30 mg once per day for 2 months placebo thrice per day, for the first month mosapride 5 mg thrice per day, for the second month | Drug | 2 |
Primary outcome
Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG)
Time frame: before enrollment, one month after treatment, two months after treatment
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 13 May 2009.
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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.
Hwai-Jeng Lin, M.D. principal investigator
Lotung Poh-Ai Hospital
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 of Gastroesophageal Reflux Disease, 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 4 inclusion and 6 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 13 May 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?
Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) (time frame: before enrollment, one month after treatment, two months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2009.