Document Detail

U.S. experience with omeprazole in duodenal ulcer. Multicenter double-blind comparative study with ranitidine. The Omeprazole DU Comparative Study Group.
MedLine Citation:
PMID:  2032518     Owner:  NLM     Status:  MEDLINE    
To assess the comparative efficacy of omeprazole 20 mg, a proton pump inhibitor, versus ranitidine 150 mg twice a day, an H2-receptor antagonist, in healing duodenal ulcers we performed a randomized, double-blind, multicenter trial in 309 patients with endoscopically diagnosed ulcers. Patients were treated for up to four weeks and were seen at week 2 and at week 4, if unhealed at week 2, for determination of ulcer status by endoscopy, review of daily self-assessment symptom diaries, and clinical laboratory including fasting serum gastrin. Gastrin levels were repeated two weeks after cessation of study medication. Evaluation of baseline demographic and laboratory parameters demonstrated no significant differences between the two groups at entry. At week 2, 42% of the omeprazole and 34% of the ranitidine-treated patients were healed (P = NS). At week 4, there was a 19% advantage in ulcer healing for the omeprazole-treated patients in comparison to those treated with ranitidine (82% vs 63%, respectively, P less than 0.05). Healing of ulcers greater than or equal to 1.0 cm occurred in 83% of those treated with omeprazole versus 37% treated with ranitidine (P less than 0.01). There were no significant differences in rate of pain relief or incidence of clinical laboratory abnormalities. Mean fasting serum gastrin value during treatment increased over the baseline in both groups, (P less than 0.05). The percent change was significantly greater with omeprazole but few patients had elevations above the upper limit of normal for the assay. Both drugs were well tolerated. Omeprazole 20 mg demonstrated superiority in healing duodenal ulcers at four weeks in comparison to ranitidine 150 mg twice daily and was more effective in healing ulcers greater than or equal to 1.0 cm.
J E Valenzuela; R G Berlin; W J Snape; T L Johnson; B I Hirschowitz; J Colon-Pagan; R S Morse; J Petrozza; G M Van Deventer; A Cagliola
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Digestive diseases and sciences     Volume:  36     ISSN:  0163-2116     ISO Abbreviation:  Dig. Dis. Sci.     Publication Date:  1991 Jun 
Date Detail:
Created Date:  1991-06-27     Completed Date:  1991-06-27     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  7902782     Medline TA:  Dig Dis Sci     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  761-8     Citation Subset:  AIM; IM    
USC School of Medicine, Department of Medicine, Los Angeles, California 90033.
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MeSH Terms
Double-Blind Method
Duodenal Ulcer / blood,  drug therapy*
Gastrins / blood
Middle Aged
Omeprazole / therapeutic use*
Ranitidine / therapeutic use*
Wound Healing / drug effects
Grant Support
Reg. No./Substance:
0/Gastrins; 66357-35-5/Ranitidine; 73590-58-6/Omeprazole

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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