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Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome

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National Taiwan University

Status and phase

Withdrawn
Phase 4

Conditions

Functional Dyspepsia
Epigastric Pain Syndrome
Post Prandial Distress Syndrome

Treatments

Radiation: gastric scintigraphy

Study type

Interventional

Funder types

Other

Identifiers

NCT00673972
200705051M

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

EPS
Active Comparator group
Description:
Patients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria.
Treatment:
Radiation: gastric scintigraphy
PDS
Active Comparator group
Description:
Patients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria.
Treatment:
Radiation: gastric scintigraphy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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