Document Detail

Australian clinical trials of omeprazole in the management of reflux oesophagitis.
MedLine Citation:
PMID:  2093019     Owner:  NLM     Status:  MEDLINE    
Two multicentre clinical trials of omeprazole in peptic oesophagitis were recently completed in Australia. In the first trial, omeprazole, 20 or 40 mg daily (n = 31), was compared with placebo (n = 32) in 63 patients. After 4 weeks, 81% of the omeprazole-treated patients were healed, as determined endoscopically, compared with 6% of the placebo-treated patients (p less than 0.0001). When the two doses of omeprazole were compared, there was a significant therapeutic advantage for the 40 mg dose at 4 weeks but by 8 weeks there was no significant difference between the two doses. This study included a 6-month surveillance phase in 107 endoscopically healed patients after cessation of omeprazole therapy. By 6 months, erosive or ulcerative oesophagitis had recurred in 82% of these patients. In the second trial, 165 patients with erosive or ulcerative oesophagitis were first healed with omeprazole, 20 mg daily. Of these patients, 159 were then enrolled in a maintenance therapy trial and randomized to three groups: ranitidine, 150 mg b.i.d., omeprazole, 20 mg daily, or omeprazole weekend therapy (i.e. omeprazole, 20 mg daily, on Friday, Saturday and Sunday only). Patients were followed for a maximum period of 12 months or until relapse. Neither ranitidine nor weekend therapy with omeprazole was effective in maintaining patients in remission. However, omeprazole, 20 mg daily, was a highly effective maintenance therapy with 89% of patients in remission after 12 months compared with only 25 and 32% for ranitidine and weekend omeprazole, respectively. All three regimens were well tolerated.
J Dent
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Digestion     Volume:  47 Suppl 1     ISSN:  0012-2823     ISO Abbreviation:  Digestion     Publication Date:  1990  
Date Detail:
Created Date:  1991-06-18     Completed Date:  1991-06-18     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0150472     Medline TA:  Digestion     Country:  SWITZERLAND    
Other Details:
Languages:  eng     Pagination:  69-71     Citation Subset:  IM    
Gastroenterology Unit, Royal Adelaide Hospital, Australia.
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MeSH Terms
Drug Administration Schedule
Esophagitis, Peptic / drug therapy*
Life Tables
Omeprazole / administration & dosage,  therapeutic use*
Reg. No./Substance:

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