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”

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.

Study Type: Interventional

Study Design: Diagnostic, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2009

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

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

Primary 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
    Safety Issue?: No

Secondary Measures

• Psychiatric distress, personality traits, infection of H. pylori and symptom improvement to lansoprazole
  • Time Frame: after four-week treatment of lansoprazole
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Taiwan University Hospital

Overall Clinical Trial Officials and Contacts

Ming-Shiang Wu, M.D.PHD Principal Investigator National Taiwan University Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00673972

Study ID Number: 200705051M

ClinicalTrials.gov Identifier: NCT00673972

Health Authority: Taiwan: Department of Health