drugset / Trial / NCT00825630

13-C Urea Breath Test Using BreathID System and PPIs (Proton Pump Inhibitors)

NCT00825630

RandomizedParallel-groupOpen-labelDiagnostic

Summary

Approximately 200 patients with suspected H.pylori will be tested with a 13C-Urea Breath Test (UBT) to ascertain H.pylori positive. 100 H.Pylori positive patients will tested before and after prescribed with one of the four selected Proton Pump Inhibitors (PPIs); 25 patients in each arm. This will provide information on the influence of PPIs on the UBT (Urea Breath Test). The aim of the trial is to observe the effect of different PPIs on the breath test and choose the optimal protocol of when to stop PPI. The hypothesis is that there will be a minimal effect on the UBT while using selected PPIs.

Timeline

Start
2008-11
Primary completion
2009-11
Completion
2009-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esomeprazole Small molecule 20 mg Oral
Comparator Lansoprazole Other / unclassified 20 mg Oral
Comparator Omeprazole Other / unclassified 30 mg Oral
Comparator Pantoprazole Other / unclassified 40 mg Oral