Lansoprazole for Subgroups of Functional Dyspepsia

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

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.

Study Overview

• Status: Terminated
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Drug: Lansoprazole; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • E-DA Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
  • Taipei, Taiwan
    • Veterans General Hospital-Taipei
  • Yun-Lin, Taiwan
    • National Taiwan University Hospital Yun-Lin Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Takeda
• Investigators: Principal Investigator: Ming-Shiang Wu, M.D.,Ph.D., National Taiwan University College of Medicine

Publications and helpful links

General Publications

• 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.

Helpful Links

• Rome Foundation

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 25, 2009
• First Submitted That Met QC Criteria: December 28, 2009
• First Posted (Estimate): December 29, 2009

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 13, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: placebo effect; functional dyspepsia; lansoprazole
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: 200907053M