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Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome

This study has been withdrawn prior to enrollment.
(difficulty in recruiting patients)
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00673972
First received: May 5, 2008
Last updated: March 8, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Functional Dyspepsia
Epigastric Pain Syndrome
Post Prandial Distress Syndrome
 Radiation: gastric scintigraphy
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

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 [ Time Frame: After four-week treatment of lansoprazole ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychiatric distress, personality traits, infection of H. pylori and symptom improvement to lansoprazole [ Time Frame: after four-week treatment of lansoprazole ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EPS
Patients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria.
 Radiation: gastric scintigraphy

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.

Other Name: gastric emptying time
Active Comparator: PDS
Patients with functional dyspepsia will be classified into EPS or PDS two subgroups according to Rome III diagnostic criteria.
 Radiation: gastric scintigraphy

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.

Other Name: gastric emptying time

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673972

Locations
Taiwan
National Taiwan University Hospital
Taipei City, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Ming-Shiang Wu, M.D.PHD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Ming-Shiang Wu, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00673972     History of Changes
Other Study ID Numbers: 200705051M
Study First Received: May 5, 2008
Last Updated: March 8, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Functional dyspepsia
Gastric emptying
Helicobacter pylori
 Lansoprazole
Epigastric pain syndrome
Postprandial distress syndrome

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Somatoform Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
 Mental Disorders
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013