Preliminary double-blind evaluation of a new, non-steroidal anti-inflammatory drug: protacine. 1980

J Münzenberg, and S Tachibana

A double-blind trial was carried out in 40 patients with various inflammatory syndromes to assess the effectiveness and tolerance of protacine, a new non-steroidal anti-inflammatory agent. Twenty in-patients with arthritis or arthrosis localized to the hip or knee were given either 150 mg protacine or 50 mg indomethacin 3-times daily, orally, for 10 days on average. Twenty patients (10 in-patients and 10 out-patients) with inflammatory disorders in different locations were given either 150 mg protacine or 200 mg oxyphenbutazone, 3-times daily, orally, for 18 days on average. Assessments were made before and after treatment of pain severity and, in the first group, of joint mobility measured in degrees of joint movement. Laboratory tests were also carried out. Side-effects were scored and reported. Except for indomethacin in the case of joint mobility, all three drugs resulted in significant improvement in the conditions tested. There were no changes in the laboratory parameters tested and only 1 patient on protacine and 1 on oxyphenbutazone reported side-effects, namely slight gastric discomfort and moderate headache, respectively. Two patients on indomethacin dropped out because of severe epigastric pain, and 2 others reported severe epigastric pain but treatment was continued. These preliminary results suggest that protacine may be at least as effective and better tolerated than indomethacin and oxyphenbutazone in such patients with acute and chronic inflammatory disorders.

UI MeSH Term Description Entries
D007210 Indoleacetic Acids Acetic acid derivatives of the heterocyclic compound indole. (Merck Index, 11th ed) Auxin,Auxins,Indolylacetic Acids,Acids, Indoleacetic,Acids, Indolylacetic
D007213 Indomethacin A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES. Amuno,Indocid,Indocin,Indomet 140,Indometacin,Indomethacin Hydrochloride,Metindol,Osmosin
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010879 Piperazines Compounds that are derived from PIPERAZINE.
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
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults

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