Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome
Information source: National Taiwan University Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Functional Dyspepsia; Epigastric Pain Syndrome; Post Prandial Distress Syndrome
Intervention: gastric scintigraphy (Radiation)
Phase: Phase 4
Status: Recruiting
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s):
Ming-Shiang Wu, M.D.PHD, Principal Investigator, Affiliation: National Taiwan University Hospital
Overall contact:
Yao-Chun Hsu, M.D., Phone: 886-2-972212053, Email: holdenhsu@ntu.edu.tw
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.
Clinical Details
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
Study design: Diagnostic, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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
Secondary outcome: Psychiatric distress, personality traits, infection of H. pylori and symptom improvement 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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- aged greater than 20 years
- fulfill Rome III diagnostic criteria
Exclusion Criteria:
- 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
Locations and Contacts
Yao-Chun Hsu, M.D., Phone: 886-2-972212053, Email: holdenhsu@ntu.edu.tw
National Taiwan University Hospital, Taipei City 100, Taiwan; Recruiting
Yao-Chun Hsu, M.D., Phone: 886-972-212053, Email: holdenhsu@ntu.edu.tw
Additional Information
Starting date: April 2008
Ending date: February 2009
Last updated: May 19, 2008
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