Lansoprazole for Subgroups of Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01040455
• Other study ID #: 200907053M
• Status: Terminated
• Phase: Phase 4
• First received: December 25, 2009
• Last updated: April 13, 2014
• Start date: December 2009
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Drug:
• Lansoprazole
lansoprazole 15mg (Takepron®, Takeda Pharmaceutical Company, Osaka, Japan) once daily for eight weeks
• placebo
placebo once daily for eight weeks

Locations

Country	Name	City	State
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Veterans General Hospital-Taipei	Taipei
Taiwan	National Taiwan University Hospital Yun-Lin Branch	Yun-Lin

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Takeda

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete relief of dyspeptic symptoms		within one week after complete study medication	No
Secondary	satisfactory therapeutic response (complete or marked relief of symptoms)		within one week after complete study medication	No
Secondary	change of dyspepsia severity as measured by total scores of Hong Kong index		within one week after completing study medication	No
Secondary	health-related quality of life as reflected in every aspect of SF-36		within one week after completing study medication	No

External Links

•   Rome Foundation