Total Antioxidant Effects of Esomeprazole in Dyspeptic Patients Receiving Non-steroidal Anti-inflammatory Drugs
Status:
Withdrawn
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
The principal investigator hypothesizes that participants receiving NSAID drugs with
dyspeptic symptoms have increased production of gastric levels of free radicals. The primary
objective of the study is to determine if Esomeprazole Magnesium increases gastric total
antioxidant capacity and decreases gastric free radical production in humans. Participants
(age 18 years and older) with no history of upper GI bleeding who are receiving non-steroidal
anti-inflammatory drugs and then develop dyspepsia will be recruited from our primary care
clinic in Washington, DC. All eligible participants will undergo biopsies of antrum and
corpus. The participants will be randomized to receive either Zantac OTC or Nexium for 15
days. On day 15, all participants will undergo repeat upper endoscopy to obtain biopsies of
antrum and corpus. Tissue samples will then be extracted to determine total antioxidant
capacity and lipid peroxide levels (as an indirect marker of free radical production).