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Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia

NCT00978159 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2012-06-06

No results posted yet for this study

Summary

Aspirin can prevent ischemic vascular disease but is commonly complicated by dyspepsia in 30% of patients. Patients, who have aspirin related dyspepsia, commonly underwent upper endoscopy to exclude peptic ulcer disease or gastric cancers. For those without significant lesions in the stomach and duodenum (non-ulcer dyspepsia), the best approach in the management is unclear. The objective of this study is to compare the efficacy of esomeprazole and famotidine in the control of dyspeptic symptom. After giving consent, patients will be randomised to receive either esomeprazole 20 mg daily or famotidine 40 mg daily in a double blinded manner. The patient will be followed-up at the 2nd and 4th week. The study will be completed at the 4th week. The primary analysis will be the efficacy in the control of dyspepsia symptom between the two groups.

Conditions

  • Aspirin
  • Dyspepsia

Interventions

DRUG

esomeprazole

esomeprazole 20 mg po for 4 weeks

DRUG

Famotidine

Famotidine 40 mg po for 4 weeks

Sponsors & Collaborators

  • Queen Mary Hospital, Hong Kong

    collaborator OTHER

  • Ruttonjee Hospital

    lead OTHER

Principal Investigators

  • FH Ng, MD · Ruttonjee Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00978159 on ClinicalTrials.gov