Functional DyspepsiaPhase 4NCT01040455
Lansoprazole for Subgroups of Functional Dyspepsia
A Phase 4 study testing Lansoprazole in people with Functional Dyspepsia, run by National Taiwan University Hospital at 4 sites in Taiwan.
Trial summary
Pharmacotherapy for functional dyspepsia remains unsatisfactory. Previous randomized trials reported conflicting results on clinical effectiveness of proton pump inhibitor in patients with functional dyspepsia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Lansoprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 4 sitesTaiwan
- Study dates
- Dec 2009to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dyspeptic adult outpatients
- Characteristic dyspeptic symptoms according to Rome III criteria (bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning)
- Upper gastrointestinal endoscopy excluding structural diseases
Who cannot join
- aged less than 20 years old,
- organic lesions such as peptic ulcer, tumor of any kind, stricture or structural deformity, erosive esophagitis, or vasculopathy on endoscopy
- typical and predominant reflux symptoms (heartburn or acid regurgitation)
- comorbidity with malignancy, diabetes mellitus, liver cirrhosis, renal failure, or porphyria
- history of intra-abdominal surgery
- concurrent use of aspirin, non-steroidal anti-inflammatory drug or proton pump inhibitor
- history of allergy or severe side effects to lansoprazole
- pregnant or lactating women.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
National Taiwan University Hospital Yun-Lin Branch
Douliu
E-Da Hospital
Kaohsiung City
National Taiwan University Hospital
Taipei, 100
Veterans General Hospital-Taipei
Taipei
About this study
Official title: Therapeutic Response to Lansoprazole Among Different Subgroups of Functional Dyspepsia: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Pharmacotherapy for functional dyspepsia remains unsatisfactory. Previous randomized trials reported conflicting results on clinical effectiveness of proton pump inhibitor in patients with functional dyspepsia. This study aims to examine whether lansoprazole 15mg is more effective than placebo for functional dyspepsia in Taiwanese patients, and to investigate the association between subgroups of patients and therapeutic response.
Read the detailed description
This is a prospective double-blind randomized placebo-controlled trial. A total of 450 dyspeptic adult patients, who are diagnosed with functional dyspepsia in accordance with Rome III criteria, are randomly allocated in a 1:1 proportion to receive either lansoprazole 15mg or placebo once daily for 8 weeks. Primary outcome is complete relief of dyspeptic symptoms. Secondary outcomes include significant symptomatic relief, improvement of dyspepsia severity, and health-related quality of life. We use a multiple logistic regression analysis to investigate whether dyspepsia subgroups are associated with different therapeutic responses.
- Conditions
- Functional Dyspepsia
- Being tested
- Lansoprazole, placebo
- Keywords
- functional dyspepsia, lansoprazole, placebo effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LansoprazoleDrug
Also called Takepron
lansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks
placeboDrug
placebo once daily for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| lansoprazole | Experimental | lansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks Receives: Drug: Lansoprazole |
| placebo | Placebo comparator | placebo once daily for eight weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete relief of dyspeptic symptoms
Measured: within one week after complete study medication
Secondary outcomes (3)
satisfactory therapeutic response (complete or marked relief of symptoms)
Measured: within one week after complete study medication
change of dyspepsia severity as measured by total scores of Hong Kong index
Measured: within one week after completing study medication
health-related quality of life as reflected in every aspect of SF-36
Measured: within one week after completing study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: failure to recruit enough patients
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Ming-Shiang Wu, M.D.,Ph.D., Principal investigator, National Taiwan University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040455
- Sponsor's protocol ID
- 200907053M
- Status last verified
- Apr 2014
- First submitted
- 25 Dec 2009
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu YC, Liou JM, Liao SC, Yang TH, Wu HT, Hsu WL, Lin HJ, Wang HP, Wu MS. Psychopathology and personality trait in subgroups of functional dyspepsia based on Rome III criteria. Am J Gastroenterol. 2009 Oct;104(10):2534-42. doi: 10.1038/ajg.2009.328. Epub 2009 Jun 16.
PubMed 19532128
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Response to Lansoprazole Among Different Subgroups of Functional Dyspepsia: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01040455
- Acronym / sponsor ID
- 200907053M
- Conditions
- Functional Dyspepsia
- Keywords
- functional dyspepsia, lansoprazole, placebo effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failure to recruit enough patients
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Dec 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Dec 2009 (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.
Pharmacotherapy for functional dyspepsia remains unsatisfactory. Previous randomized trials reported conflicting results on clinical effectiveness of proton pump inhibitor in patients with functional dyspepsia. This study aims to examine whether lansoprazole 15mg is more effective than placebo for functional dyspepsia in Taiwanese patients, and to investigate the association between subgroups of patients and therapeutic response.
Detailed description
This is a prospective double-blind randomized placebo-controlled trial. A total of 450 dyspeptic adult patients, who are diagnosed with functional dyspepsia in accordance with Rome III criteria, are randomly allocated in a 1:1 proportion to receive either lansoprazole 15mg or placebo once daily for 8 weeks. Primary outcome is complete relief of dyspeptic symptoms. Secondary outcomes include significant symptomatic relief, improvement of dyspepsia severity, and health-related quality of life. We use a multiple logistic regression analysis to investigate whether dyspepsia subgroups are associated with different therapeutic responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lansoprazole | Experimental | Drug: Lansoprazolelansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks |
| placebo | Placebo comparator | Drug: placeboplacebo once daily for eight weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dyspeptic adult outpatients
- Characteristic dyspeptic symptoms according to Rome III criteria (bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning)
- Upper gastrointestinal endoscopy excluding structural diseases
Key exclusion criteria (8 listed)
- aged less than 20 years old,
- organic lesions such as peptic ulcer, tumor of any kind, stricture or structural deformity, erosive esophagitis, or vasculopathy on endoscopy
- typical and predominant reflux symptoms (heartburn or acid regurgitation)
- comorbidity with malignancy, diabetes mellitus, liver cirrhosis, renal failure, or porphyria
- history of intra-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: Takepronlansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks | Drug | lansoprazole |
| placeboplacebo once daily for eight weeks | Drug | placebo |
Primary outcome
complete relief of dyspeptic symptoms
Time frame: within one week after complete study medication
3 secondary outcomes
satisfactory therapeutic response (complete or marked relief of symptoms)
Time frame: within one week after complete study medication
change of dyspepsia severity as measured by total scores of Hong Kong index
Time frame: within one week after completing study medication
health-related quality of life as reflected in every aspect of SF-36
Time frame: within one week after completing study medication
Results and safety
The study was stopped early (reason given: failure to recruit enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Background: PubMed 19532128Hsu YC, Liou JM, Liao SC, Yang TH, Wu HT, Hsu WL, Lin HJ, Wang HP, Wu MS. Psychopathology and personality trait in subgroups of functional dyspepsia based on Rome III criteria. Am J Gastroenterol. 2009 Oct;104(10):2534-42. doi: 10.1038/ajg.2009.328. Epub 2009 Jun 16.
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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.
Ming-Shiang Wu, M.D.,Ph.D. principal investigator
National Taiwan University College of Medicine
4 sites 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 in people with Functional Dyspepsia, run by National Taiwan University Hospital at 4 sites 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: stopped early, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: failure to recruit enough patients). Results are not available in the source record.
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?
complete relief of dyspeptic symptoms (time frame: within one week after complete study medication). 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 NCT01040455, 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 15 Apr 2014.