Functional DyspepsiaPhase 4NCT00673972
Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome
A Phase 4 study testing gastric scintigraphy in people with Functional Dyspepsia and Epigastric Pain Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to compare postprandial distress syndrome and epigastric pain syndrome in demographics psychological features, infection of Helicobacter pylori, gastric emptying and therapeutic response to lansoprazole. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Functional Dyspepsia, Epigastric Pain Syndrome, Post Prandial Distress Syndrome
- What is being tested?
- gastric scintigraphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2008to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged greater than 20 years
- fulfill Rome III diagnostic criteria
Who cannot join
- children and teenagers aged less than 20 years
- Organic lesions such as 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 lansoparzole
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome in Personality, Helicobacter Pylori Infection, Gastric Emptying and Response to Lansoprazole Treatment
The purpose of this study is to compare postprandial distress syndrome and epigastric pain syndrome in demographics psychological features, infection of Helicobacter pylori, gastric emptying and therapeutic response to lansoprazole.
Read the detailed description
Functional dyspepsia is a common clinical disorder with significant impact on quality of life and with enormous social cost. Previous studies have revealed that functional dyspepsia is not a homogenous disease but a heterogenous symptom complex. Because of heterogeneity in etiology and pathogenesis, no specific treatment is appropriate for all patients with functional dyspepsia. Currently available treatments demonstrated efficacy only in subsets of patients.
Appropriate subgrouping of functional dyspepsia, which categorizes more homogenous patients into the same group, will correlate better with specific etiologic factors and pathogenetic mechanisms. Consequently patients may have appropriate specific treatment based on more directed pathologenesis and subgrouping. To this end, American Gastroenterology Association launched new edition of clinical guide for functional gastrointestinal disorder, the Rome III in May 2006. The new diagnostic criteria of Rome III de-emphasized functional dyspepsia as an entity and recommended sub-classification into two conditions: postprandial distress syndrome and epigastric pain syndrome. However whether this new diagnostic criteria and systems are effective and clinically relevant remains unknown.
Aims:
We aim to compare postprandial distress syndrome and epigastric pain syndrome in demographics psychological features, infection of Helicobacter pylori, gastric emptying and therapeutic response to lansoprazole.
- Being tested
- gastric scintigraphy
- Keywords
- Functional dyspepsia, Gastric emptying, Helicobacter pylori, Lansoprazole, Epigastric pain syndrome, Postprandial distress syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric scintigraphyRadiation
Also called gastric emptying time
All tests start after overnight fast. Test meals consists of 120g scrambled egg, two slices of toasted bread, 30g of strawberry jam and 120ml of water. 12MBg (0.33mCi) of 99mTc sulfur colloid is mixed with egg thoroughly before the mixture cooked in a microwave oven for 2 minutes. All meals are prepared on the morning of examination and consumed within 20 minutes.
Anterior and posterior images of the gastric region are taken within one minute after completion of test meals. Subsequent images are taken every 2 minutes in the first 60 minutes and at 120 minutes and 180 minutes. One-min images of gastric region at upright position are taken in the 140keV 99mTc peak with a 20% window.
| Study group | Role | What they receive |
|---|---|---|
| EPS | Active comparator | Patients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria. Receives: Radiation: gastric scintigraphy |
| PDS | Active comparator | Patients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria. Receives: Radiation: gastric scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary end point of the study is to compare the gastric emptying time in epigastric pain syndrome and that in postprandial distress syndrome
Measured: After four-week treatment of lansoprazole
Secondary outcomes (1)
Psychiatric distress, personality traits, infection of H. pylori and symptom improvement to lansoprazole
Measured: after four-week treatment of lansoprazole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2009 (estimated)
- Study completionDec 2009 (estimated)
Why it stopped: difficulty in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ming-Shiang Wu, M.D.PHD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673972
- Sponsor's protocol ID
- 200705051M
- Status last verified
- Mar 2010
- First submitted
- 5 May 2008
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome in Personality, Helicobacter Pylori Infection, Gastric Emptying and Response to Lansoprazole Treatment
- ClinicalTrials.gov ID
- NCT00673972
- Acronym / sponsor ID
- 200705051M
- Keywords
- Functional dyspepsia, Gastric emptying, Helicobacter pylori, Lansoprazole, Epigastric pain syndrome, Postprandial distress syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulty in recruiting patients
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 7 May 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.
The purpose of this study is to compare postprandial distress syndrome and epigastric pain syndrome in demographics psychological features, infection of Helicobacter pylori, gastric emptying and therapeutic response to lansoprazole.
Detailed description
Functional dyspepsia is a common clinical disorder with significant impact on quality of life and with enormous social cost. Previous studies have revealed that functional dyspepsia is not a homogenous disease but a heterogenous symptom complex. Because of heterogeneity in etiology and pathogenesis, no specific treatment is appropriate for all patients with functional dyspepsia. Currently available treatments demonstrated efficacy only in subsets of patients.
Appropriate subgrouping of functional dyspepsia, which categorizes more homogenous patients into the same group, will correlate better with specific etiologic factors and pathogenetic mechanisms. Consequently patients may have appropriate specific treatment based on more directed pathologenesis and subgrouping. To this end, American Gastroenterology Association launched new edition of clinical guide for functional gastrointestinal disorder, the Rome III in May 2006. The new diagnostic criteria of Rome III de-emphasized functional dyspepsia as an entity and recommended sub-classification into two conditions: postprandial distress syndrome and epigastric pain syndrome. However whether this new diagnostic criteria and systems are effective and clinically relevant remains unknown.
Aims:
We aim to compare postprandial distress syndrome and epigastric pain syndrome in demographics psychological features, infection of Helicobacter pylori, gastric emptying and therapeutic response to lansoprazole.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPS | Active comparator | Radiation: gastric scintigraphyPatients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria. |
| PDS | Active comparator | Radiation: gastric scintigraphyPatients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged greater than 20 years
- fulfill Rome III diagnostic criteria
Key exclusion criteria (8 listed)
- children and teenagers aged less than 20 years
- Organic lesions such as 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 |
|---|---|---|
| gastric scintigraphyAlso: gastric emptying timeAll tests start after overnight fast. Test meals consists of 120g scrambled egg, two slices of toasted bread, 30g of strawberry jam and 120ml of water. 12MBg (0.33mCi) of 99mTc sulfur colloid is mixed with egg thoroughly before the mixture cooked in a microwave oven for 2 minutes. All meals are prepared on the morning of examination and consumed within 20 minutes. Anterior and posterior images of the gastric region are taken within one minute after completion of test meals. Subsequent images are taken every 2 minutes in the first 60 minutes and at 120 minutes and 180 minutes. One-min images of gastric region at upright position are taken in the 140keV 99mTc peak with a 20% window. | Radiation | EPS, PDS |
Primary outcome
Primary end point of the study is to compare the gastric emptying time in epigastric pain syndrome and that in postprandial distress syndrome
Time frame: After four-week treatment of lansoprazole
1 secondary outcome
Psychiatric distress, personality traits, infection of H. pylori and symptom improvement to lansoprazole
Time frame: after four-week treatment of lansoprazole
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2010.
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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.PHD principal investigator
National Taiwan University 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 testing gastric scintigraphy in people with Functional Dyspepsia and Epigastric Pain Syndrome, run by National Taiwan University 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 2 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: withdrawn, as of the sponsor's last update on 10 Mar 2010. 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 was withdrawn before enrolling participants, so there are no results.
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?
Primary end point of the study is to compare the gastric emptying time in epigastric pain syndrome and that in postprandial distress syndrome (time frame: After four-week treatment of lansoprazole). 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 10 Mar 2010.