Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT00673972

Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome

A Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome in Personality, Helicobacter Pylori Infection, Gastric Emptying and Response to Lansoprazole Treatment

Status
Withdrawn
Phase
Phase 4
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
National Taiwan University Hospital · Academic / Other
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
RADIATIONgastric scintigraphyAll 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.

Timeline

Start date
2008-04-01
Primary completion
2009-11-01
Completion
2009-12-01
First posted
2008-05-07
Last updated
2010-03-10

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT00673972. Inclusion in this directory is not an endorsement.