A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin

Phase 3 Completed 1045 enrolled Takeda

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to compare the gastroduodenal ulceration rate, gastrointestinal complication rate and non-steroidal anti-inflammatory drug-associated dyspepsia between lansoprazole, naproxen and celecoxib, taken once daily (QD) or twice daily (BID), in participants with osteoarthritis taking low dose aspirin.

Timeline

Start: 2003-07
Primary completion: 2004-07
Completion: 2004-07

Publications

Results Goldstein JL, Cryer B, Amer F, Hunt B. Celecoxib plus aspirin versus naproxen and lansoprazole plus aspirin: a randomized, double-blind, endoscopic trial. Clin Gastroenterol Hepatol. 2007 Oct;5(10):1167-74. doi: 10.1016/j.cgh.2007.06.009.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Celecoxib	Other / unclassified	200 mg	Oral
Subject	Lansoprazole	Other / unclassified	30 mg	Oral
Subject	Naproxen	Small molecule	500 mg	Oral
Comparator	Aspirin	Small molecule	81 mg	Oral
Comparator	Aspirin	Small molecule	325 mg	Oral

A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin

Summary

Timeline

Publications

Drugs

Indications