Abstract | OBJECTIVE: METHODS: This was a two-center, double-blind, randomized, placebo-controlled study. Healthy subjects aged 65-75 yr who were shown at baseline endoscopy to have no gastric or duodenal lesions received either parecoxib sodium 40 mg b.i.d. for 7 days, ketorolac 15 mg q.i.d. for 5 days, or placebo for 7 days. Endoscopy was repeated at the end of dosing. Measures of upper GI effects were: 1) ulceration, 2) incidence of an ulcer and/or any erosions, and 3) incidence of an ulcer and/or > or = 11 erosions in the stomach, duodenum, or both. RESULTS: CONCLUSIONS: These results indicate that multiple dose administration of parecoxib sodium is safe and well tolerated in healthy elderly subjects, with a decreased risk of gastroduodenal mucosal injury compared with ketorolac.
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Authors | Randall R Stoltz, Stuart I Harris, Michael E Kuss, Diane LeComte, Sheela Talwalker, Shobha Dhadda, Richard C Hubbard |
Journal | The American journal of gastroenterology
(Am J Gastroenterol)
Vol. 97
Issue 1
Pg. 65-71
(Jan 2002)
ISSN: 0002-9270 [Print] United States |
PMID | 11808971
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Isoxazoles
- parecoxib
- Ketorolac
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Topics |
- Age Factors
- Aged
- Confidence Intervals
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Duodenal Ulcer
(chemically induced, epidemiology, pathology)
- Female
- Gastric Mucosa
(drug effects, pathology)
- Gastroscopy
- Humans
- Incidence
- Infusions, Intravenous
- Intestinal Mucosa
(drug effects, pathology)
- Isoxazoles
(administration & dosage, adverse effects)
- Ketorolac
(administration & dosage, adverse effects)
- Male
- Reference Values
- Risk Assessment
- Stomach Ulcer
(chemically induced, epidemiology, pathology)
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