Lansoprazole for Subgroups of Functional Dyspepsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01040455
Recruitment Status : Terminated (failure to recruit enough patients)
First Posted : December 29, 2009
Last Update Posted : April 15, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Lansoprazole Drug: placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Response to Lansoprazole Among Different Subgroups of Functional Dyspepsia: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Study Start Date : December 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

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 Name: Takepron

Placebo Comparator: placebo
placebo once daily for eight weeks
Drug: placebo
placebo once daily for eight weeks

Primary Outcome Measures :
  1. complete relief of dyspeptic symptoms [ Time Frame: within one week after complete study medication ]

Secondary Outcome Measures :
  1. satisfactory therapeutic response (complete or marked relief of symptoms) [ Time Frame: within one week after complete study medication ]
  2. change of dyspepsia severity as measured by total scores of Hong Kong index [ Time Frame: within one week after completing study medication ]
  3. health-related quality of life as reflected in every aspect of SF-36 [ Time Frame: within one week after completing study medication ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01040455

E-Da Hospital
Kaohsiung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Veterans General Hospital-Taipei
Taipei, Taiwan
National Taiwan University Hospital Yun-Lin Branch
Yun-Lin, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Ming-Shiang Wu, M.D.,Ph.D. National Taiwan University College of Medicine

Additional Information:
Responsible Party: National Taiwan University Hospital Identifier: NCT01040455     History of Changes
Other Study ID Numbers: 200907053M
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by National Taiwan University Hospital:
functional dyspepsia
placebo effect

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action