Comparative Study of Epigastric Pain Syndrome and Postprandial Distress Syndrome

NCT00673972 | Withdrawn Phase 4 DMC

• 1 other identifier: 200705051M
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia; Epigastric Pain Syndrome; Post Prandial Distress Syndrome

Keywords

Functional dyspepsia; Gastric emptying; Helicobacter pylori; Lansoprazole; Epigastric pain syndrome; Postprandial distress syndrome

Outcome Measures

Primary Outcomes (1)

• Primary end point of the study is to compare the gastric emptying time in epigastric pain syndrome and that in postprandial distress syndrome

  After four-week treatment of lansoprazole

Secondary Outcomes (1)

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

  after four-week treatment of lansoprazole

Study Arms (2)

EPS

ACTIVE COMPARATOR

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

Radiation: gastric scintigraphy

PDS

ACTIVE COMPARATOR

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

Radiation: gastric scintigraphy

Interventions

gastric scintigraphy RADIATION

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.

Also known as: gastric emptying time

EPS; PDS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged greater than 20 years
• fulfill Rome III diagnostic criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

• Ming-Shiang Wu, M.D.PHD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 10, 2010

Record last verified: 2010-03

Locations

TW (1)