Clinical trial on the efficacy and safety of different diclofenac formulations: Multiple-unit formulations compared to enteric coated tablets in patients with activated osteoarthritis

Autor:	K. Walter, W. Schmitt, H. J. Kurth
Rok vydání:	1999
Předmět:	Pharmacology business.industry Visual analogue scale Standard treatment Immunology Osteoarthritis Diclofenac Sodium medicine.disease Placebo Regimen Diclofenac Tolerability Anesthesia medicine Pharmacology (medical) business medicine.drug
Zdroj:	Inflammopharmacology. 7:363-375
ISSN:	1568-5608 0925-4692
DOI:	10.1007/s10787-999-0030-z
Popis:	—This double-blind, randomised, multicentre study investigated the efficacy and safety of two different dosages of a diclofenac sodium dual release capsule (150 mg or 75 mg once daily) in comparison to a standard treatment with enteric coated tablets (50 mg t.i.d.) and placebo in patients with activated osteoarthritis. Pain relief as the main efficacy variable was measured through 24 hours by means of a Visual Analogue Scale at baseline and on five assessment days during the 12 weeks of treatment. Efficacy was observed in all treatment groups with a statistically significant difference between the verum groups and placebo. The overall safety and tolerability of the active treatments was good. For the 75 mg group, a lower incidence of liver and biliary system-related side effects was reported. Considering efficacy, safety, and compliance aspects, the once daily administration of diclofenac sodium 75 mg dual release capsule is the appropriate dosage regimen for mid- and long-term treatment of osteoarthritis.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f174253bb9eadd1f7d85d3457a4ea33a https://doi.org/10.1007/s10787-999-0030-z Zobrazit plný text záznamu Plný text ve formátu PDF