A double-blind crossover evaluation of ketoprofen (Orudis) and placebo in rheumatoid arthritis with assessment of long-term tolerance. 1978

D L Howard

A two-week double-blind crossover study of ketoprofen, a non-steroidal antiinflammatory agent, and placebo was done in ten patients with active rheumatoid arthritis in order to obtain a preliminary efficacy estimate of this new drug. Even after only one week of treatment, joint activity was significantly reduced while other parameters of disease activity showed strong clinical trends in favour of the drug. Only one adverse reaction (mild nausea) was reported during ketoprofen therapy. At the conclusion of the double-blind study, seven patients volunteered to continue on ketoprofen to evaluate the tolerance of the drug during proptracted administration. All patients completed over twelve months of treatment. Overall, ketoprofen gave good control of pain and inflammation, gastro-intestinal disturbance was reported in a single instance and laboratory values were not adversely affected by the drug.

UI MeSH Term Description Entries
D007660 Ketoprofen An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis. Benzoylhydratropic Acid,19,583 RP,2-(3-Benzoylphenyl)propionic Acid,Alrheumat,Alrheumum,Orudis,Profenid,RP-19583,RP 19583,RP, 19,583,RP19583
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010666 Phenylpropionates Derivatives of 3-phenylpropionic acid, including its salts and esters.
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly

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