Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome

Phase 4

Withdrawn

• Conditions: Functional Dyspepsia; Epigastric Pain Syndrome; Post Prandial Distress Syndrome
• Interventions: Radiation: gastric scintigraphy

• Registration Number: NCT00673972
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-07
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-08
• Last Update Posted: 2010-03-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• aged greater than 20 years
• fulfill Rome III diagnostic criteria

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPS	gastric scintigraphy	Patients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria.
PDS	gastric scintigraphy	Patients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria.

Primary Outcome Measures

Name	Time	Method
Primary end point of the study is to compare the gastric emptying time in epigastric pain syndrome and that in postprandial distress syndrome	After four-week treatment of lansoprazole

Secondary Outcome Measures

Name	Time	Method
Psychiatric distress, personality traits, infection of H. pylori and symptom improvement to lansoprazole	after four-week treatment of lansoprazole

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan