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Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome

Primary Purpose

Functional Dyspepsia, Epigastric Pain Syndrome, Post Prandial Distress Syndrome

Status
Withdrawn
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
gastric scintigraphy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Functional Dyspepsia focused on measuring Functional dyspepsia, Gastric emptying, Helicobacter pylori, Lansoprazole, Epigastric pain syndrome, Postprandial distress syndrome

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EPS

PDS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 Measures

Psychiatric distress, personality traits, infection of H. pylori and symptom improvement to lansoprazole

Full Information

First Posted
May 5, 2008
Last Updated
March 8, 2010
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00673972
Brief Title
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

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Withdrawn
Why Stopped
difficulty in recruiting patients
Study Start Date
April 2008 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Epigastric Pain Syndrome, Post Prandial Distress Syndrome
Keywords
Functional dyspepsia, Gastric emptying, Helicobacter pylori, Lansoprazole, Epigastric pain syndrome, Postprandial distress syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EPS
Arm Type
Active Comparator
Arm Description
Patients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria.
Arm Title
PDS
Arm Type
Active Comparator
Arm Description
Patients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria.
Intervention Type
Radiation
Intervention Name(s)
gastric scintigraphy
Other Intervention Name(s)
gastric emptying time
Intervention Description
All 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.
Primary Outcome Measure Information:
Title
Primary end point of the study is to compare the gastric emptying time in epigastric pain syndrome and that in postprandial distress syndrome
Time Frame
After four-week treatment of lansoprazole
Secondary Outcome Measure Information:
Title
Psychiatric distress, personality traits, infection of H. pylori and symptom improvement to lansoprazole
Time Frame
after four-week treatment of lansoprazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shiang Wu, M.D.PHD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome

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