Lansoprazole for Subgroups of Functional Dyspepsia

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Pharmacotherapy for functional dyspepsia remains unsatisfactory. Previous randomized trials reported conflicting results on clinical effectiveness of proton pump inhibitor in patients with functional dyspepsia. This study aims to examine whether lansoprazole 15mg is more effective than placebo for functional dyspepsia in Taiwanese patients, and to investigate the association between subgroups of patients and therapeutic response.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborator: Takeda
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

• Dyspeptic adult outpatients

• Characteristic dyspeptic symptoms according to Rome III criteria (bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning)

• Upper gastrointestinal endoscopy excluding structural diseases

Exclusion Criteria:

• aged less than 20 years old,

• organic lesions such as peptic ulcer, tumor of any kind, stricture or structural deformity, erosive esophagitis, or vasculopathy on endoscopy

• typical and predominant reflux symptoms (heartburn or acid regurgitation)

• comorbidity with malignancy, diabetes mellitus, liver cirrhosis, renal failure, or porphyria

• history of intra-abdominal surgery

• concurrent use of aspirin, non-steroidal anti-inflammatory drug or proton pump inhibitor

• history of allergy or severe side effects to lansoprazole

• pregnant or lactating women.