Clinical trial NCT01040455: Lansoprazole for Subgroups of Functional Dyspepsia
Official title: Therapeutic Response to Lansoprazole Among Different Subgroups of Functional Dyspepsia: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Functional Dyspepsia
Keywords: functional dyspepsia
lansoprazole
placebo effect
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2009-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: complete relief of dyspeptic symptoms
timeFrame: within one week after complete study medication
Secondary outcomes:
measure: satisfactory therapeutic response (complete or marked relief of symptoms)
timeFrame: within one week after complete study medication
measure: change of dyspepsia severity as measured by total scores of Hong Kong index
timeFrame: within one week after completing study medication
measure: health-related quality of life as reflected in every aspect of SF-36
timeFrame: within one week after completing study medication
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Veterans General Hospital-Taipei
city: Yun-Lin
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
Study officials:
affiliation: National Taiwan University College of Medicine
name: Ming-Shiang Wu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu YC, Liou JM, Liao SC, Yang TH, Wu HT, Hsu WL, Lin HJ, Wang HP, Wu MS. Psychopathology and personality trait in subgroups of functional dyspepsia based on Rome III criteria. Am J Gastroenterol. 2009 Oct;104(10):2534-42. doi: 10.1038/ajg.2009.328. Epub 2009 Jun 16.