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Lansoprazole for Subgroups of Functional Dyspepsia

Primary Purpose

Functional Dyspepsia

Status
Terminated
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Lansoprazole
placebo
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring functional dyspepsia, lansoprazole, placebo effect

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • E-Da Hospital
  • National Taiwan University Hospital
  • Veterans General Hospital-Taipei
  • National Taiwan University Hospital Yun-Lin Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

lansoprazole

placebo

Arm Description

lansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks

placebo once daily for eight weeks

Outcomes

Primary Outcome Measures

complete relief of dyspeptic symptoms

Secondary Outcome Measures

satisfactory therapeutic response (complete or marked relief of symptoms)
change of dyspepsia severity as measured by total scores of Hong Kong index
health-related quality of life as reflected in every aspect of SF-36

Full Information

First Posted
December 25, 2009
Last Updated
April 13, 2014
Sponsor
National Taiwan University Hospital
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT01040455
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
failure to recruit enough patients
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
functional dyspepsia, lansoprazole, placebo effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lansoprazole
Arm Type
Experimental
Arm Description
lansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo once daily for eight weeks
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
Takepron
Intervention Description
lansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo once daily for eight weeks
Primary Outcome Measure Information:
Title
complete relief of dyspeptic symptoms
Time Frame
within one week after complete study medication
Secondary Outcome Measure Information:
Title
satisfactory therapeutic response (complete or marked relief of symptoms)
Time Frame
within one week after complete study medication
Title
change of dyspepsia severity as measured by total scores of Hong Kong index
Time Frame
within one week after completing study medication
Title
health-related quality of life as reflected in every aspect of SF-36
Time Frame
within one week after completing study medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shiang Wu, M.D.,Ph.D.
Organizational Affiliation
National Taiwan University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
E-Da Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Veterans General Hospital-Taipei
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital Yun-Lin Branch
City
Yun-Lin
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
19532128
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.
Results Reference
background
Links:
URL
http://www.romecriteria.org/
Description
Rome Foundation

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Lansoprazole for Subgroups of Functional Dyspepsia

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