Naprelan Clinical Trials and Studies
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Naprelan Clinical Trials and Studies
Rheumatoid Arthritis
The use of Naprelan for the management of the signs and symptoms of rheumatoid arthritis was assessed in a 12 week double-blind, randomized, placebo and active-controlled study in 348 patients. Two Naprelan 500 mg tablets (1000 mg) once daily and naproxen 500 mg tablets twice daily (1000 mg) were more effective than placebo. Clinical effectiveness was demonstrated at one week and continued for the duration of the study.
Osteoarthritis
The use of Naprelan for the management of the signs and symptoms of osteoarthritis of the knee was assessed in a 12 week double-blind, placebo and active-controlled study in 347 patients. Two Naprelan 500 mg tablets (1000 mg) once daily and naproxen 500 mg tablets twice daily (1000 mg) were more effective than placebo. Clinical effectiveness was demonstrated at one week and continued for the duration of the study.
Analgesia
The onset of the analgesic effect of Naprelan was seen within 30 minutes in a pharmacokinetic/pharmacodynamic study of patients with pain following oral surgery. In controlled clinical trials, Naprelan (naproxen) has been used in combination with gold, D-penicillamine, methotrexate and corticosteroids. Its use in combination with salicylate is not recommended because there is evidence that aspirin increases the rate of excretion of naproxen and data are inadequate to demonstrate that naproxen and aspirin produce greater improvement over that achieved with aspirin alone. In addition with Naprelan, as with other NSAIDs, the combination may result in higher frequency of adverse events than demonstrated for either product alone.
Special Studies
In a double-blind randomized, parallel group study, 19 subjects received either two Naprelan 500 mg tablets (1000 mg) once daily or naproxen 500 mg tablets (1000 mg) twice daily for 7 days. Mucosal biopsy scores and endoscopic scores were lower in the subjects who received Naprelan. In another double-blind, randomized, crossover study, 23 subjects received two Naprelan 500 mg tablets (1000 mg) once daily, naproxen 500 mg tablets (1000 mg) twice daily and aspirin 650 mg four times daily (2600 mg) for 7 days each. There were significantly fewer duodenal erosions seen with Naprelan than with either naproxen or aspirin. There were significantly fewer gastric erosions with both Naprelan and naproxen than with aspirin.
The clinical significance of these findings is unknown.
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