Lansoprazole for Subgroups of Functional Dyspepsia

National Taiwan University

Status and phase

Terminated

Phase 4

Conditions

Functional Dyspepsia

Treatments

Drug: placebo

Drug: Lansoprazole

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01040455

200907053M

Details and patient eligibility

About

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.

Full description

This is a prospective double-blind randomized placebo-controlled trial. A total of 450 dyspeptic adult patients, who are diagnosed with functional dyspepsia in accordance with Rome III criteria, are randomly allocated in a 1:1 proportion to receive either lansoprazole 15mg or placebo once daily for 8 weeks. Primary outcome is complete relief of dyspeptic symptoms. Secondary outcomes include significant symptomatic relief, improvement of dyspepsia severity, and health-related quality of life. We use a multiple logistic regression analysis to investigate whether dyspepsia subgroups are associated with different therapeutic responses.

Enrollment

30 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.