Document Detail


Prevention of duodenal ulcer relapse with omeprazole 20 mg daily: a randomized double-blind, placebo-controlled study.
MedLine Citation:
PMID:  7620115     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
We report the first double-blind, placebo-controlled study that assesses the efficacy and safety of omeprazole 20 mg daily in the maintenance treatment of duodenal ulcer. For the healing phase, 128 patients with endoscopically proven active duodenal ulcer and a history of three or more relapses during the 2 years prior to the study were treated until healing with omeprazole 40 mg daily for 2 and up to 8 weeks. One hundred and twenty-three patients whose ulcers were healed were randomized to receive omeprazole 20 mg daily (n = 60) or placebo (n = 63) for 12 months as maintenance treatment. Patients were interviewed at 3, 6, 9 and 12 months, and endoscopy was performed at 3, 6 and 12 months and whenever symptoms recurred. The healing rates of the 124 patients completing the healing phase were 84, 98 and 100% at 2, 4 and 8 weeks, respectively. During the maintenance phase, eight and four patients discontinued treatment from the omeprazole and placebo groups, respectively. The proportion of patients in remission in the omeprazole group and placebo group after 12 months were 94 and 9% respectively (life table estimates, P < 0.0001). No significant clinical or laboratory changes were observed in patients on therapy with omeprazole. Patients with a history of frequent relapses thus continued to have a very high relapse rate without prophylactic treatment. Omeprazole 20 mg daily was effective and safe in maintaining such patients in remission.
Authors:
K L Goh; S Boonyapisit; K H Lai; R Chang; J Y Kang; S K Lam
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of gastroenterology and hepatology     Volume:  10     ISSN:  0815-9319     ISO Abbreviation:  J. Gastroenterol. Hepatol.     Publication Date:    1995 Jan-Feb
Date Detail:
Created Date:  1995-08-29     Completed Date:  1995-08-29     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  8607909     Medline TA:  J Gastroenterol Hepatol     Country:  AUSTRALIA    
Other Details:
Languages:  eng     Pagination:  92-7     Citation Subset:  IM    
Affiliation:
University Hospital, Kuala Lumpur, Malaysia.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Double-Blind Method
Drug Administration Schedule
Duodenal Ulcer / prevention & control*
Female
Humans
Male
Middle Aged
Omeprazole / administration & dosage*
Recurrence
Treatment Outcome
Chemical
Reg. No./Substance:
73590-58-6/Omeprazole
Comments/Corrections
Comment In:
J Gastroenterol Hepatol. 1995 Jan-Feb;10(1):110-1   [PMID:  7620100 ]

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


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