drugset / Trial / NCT00978159

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

NCT00978159

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-09
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esomeprazole Small molecule 20 mg Oral
Comparator Famotidine Other / unclassified 40 mg Oral

Indications