NCT01040455

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 15, 2014

Status Verified

April 1, 2014

Enrollment Period

4 years

First QC Date

December 25, 2009

Last Update Submit

April 13, 2014

Conditions

Functional Dyspepsia

Keywords

functional dyspepsialansoprazoleplacebo effect

Outcome Measures

Primary Outcomes (1)

  • complete relief of dyspeptic symptoms

    within one week after complete study medication

Secondary Outcomes (3)

  • 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

Study Arms (2)

lansoprazole

EXPERIMENTAL

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

Drug: Lansoprazole

placebo

PLACEBO COMPARATOR

placebo once daily for eight weeks

Drug: placebo

Interventions

LansoprazoleDRUG

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

Also known as: Takepron
lansoprazole
placeboDRUG

placebo once daily for eight weeks

placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

National Taiwan University Hospital Yun-Lin Branch

Douliu, Taiwan

Location

E-Da Hospital

Kaohsiung City, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Veterans General Hospital-Taipei

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 19532128BACKGROUND

Related Links

MeSH Terms

Interventions

Lansoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ming-Shiang Wu, M.D.,Ph.D.

    National Taiwan University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2009

First Posted

December 29, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 15, 2014

Record last verified: 2014-04

Locations

TW(4)