Lansoprazole for Subgroups of Functional Dyspepsia

This study has been terminated.
(failure to recruit enough patients)
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01040455
First received: December 25, 2009
Last updated: April 13, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Functional Dyspepsia
Drug: Lansoprazole
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Therapeutic Response to Lansoprazole Among Different Subgroups of Functional Dyspepsia: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • complete relief of dyspeptic symptoms [ Time Frame: within one week after complete study medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • satisfactory therapeutic response (complete or marked relief of symptoms) [ Time Frame: within one week after complete study medication ] [ Designated as safety issue: No ]
  • change of dyspepsia severity as measured by total scores of Hong Kong index [ Time Frame: within one week after completing study medication ] [ Designated as safety issue: No ]
  • health-related quality of life as reflected in every aspect of SF-36 [ Time Frame: within one week after completing study medication ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2009
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040455

Locations
Taiwan
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
Takeda
Investigators
Principal Investigator: Ming-Shiang Wu, M.D.,Ph.D. National Taiwan University College of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01040455     History of Changes
Other Study ID Numbers: 200907053M
Study First Received: December 25, 2009
Last Updated: April 13, 2014
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014