Clinical trial NCT00673972: Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Functional Dyspepsia
Epigastric Pain Syndrome
Post Prandial Distress Syndrome
Keywords: Functional dyspepsia
Gastric emptying
Helicobacter pylori
Lansoprazole
Epigastric pain syndrome
Postprandial distress syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Primary end point of the study is to compare the gastric emptying time in epigastric pain syndrome and that in postprandial distress syndrome
timeFrame: After four-week treatment of lansoprazole
Secondary outcomes:
measure: Psychiatric distress, personality traits, infection of H. pylori and symptom improvement to lansoprazole
timeFrame: after four-week treatment of lansoprazole
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ming-Shiang Wu, M.D.PHD
role: PRINCIPAL_INVESTIGATOR
References: