Lansoprazole for Subgroups of Functional Dyspepsia

Phase 4

Terminated

• Conditions: Functional Dyspepsia
• Interventions: Drug: placebo; Drug: Lansoprazole

• Registration Number: NCT01040455
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-25
• Study First Submitted QC: 2009-12-28
• Study First Posted: 2009-12-29
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-13
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo once daily for eight weeks
lansoprazole	Lansoprazole	lansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks

Primary Outcome Measures

Name	Time	Method
complete relief of dyspeptic symptoms	within one week after complete study medication

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

E-Da Hospital; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital Yun-Lin Branch; 🇨🇳 Yun-Lin, Taiwan

Veterans General Hospital-Taipei; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan