Lansoprazole for Subgroups of Functional Dyspepsia

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Therapeutic Response to Lansoprazole Among Different Subgroups of Functional Dyspepsia: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Conditions
-----------------
Functional Dyspepsia

Intervention / Treatment
-----------------
* Drug: Lansoprazole
* Drug: placebo


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lansoprazole<br>lansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks | Drug: Lansoprazole<br>* lansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks<br>* Other names: Takepron;|
| Placebo Comparator: placebo<br>placebo once daily for eight weeks | Drug: placebo<br>* placebo once daily for eight weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete relief of dyspeptic symptoms |  | within one week after complete study medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satisfactory therapeutic response (complete or marked relief of symptoms) |  | within one week after complete study medication | 
| change of dyspepsia severity as measured by total scores of Hong Kong index |  | within one week after completing study medication | 
| health-related quality of life as reflected in every aspect of SF-36 |  | within one week after completing study medication | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
functional dyspepsia, lansoprazole, placebo effect