The rise and fall of a new anti-inflammatory analgesic.
The efficacy of a new non-steroidal anti-inflammatory drug (NSAID), GP 53.633 (GP), was tested versus placebo in a double-blind cross-over study. 24 healthy young individuals with impacted asymptomatic lower third molars, of similar shape and position in the jaw on both sides, underwent surgery on 2 separate occasions. The patients randomly received the active drug at one and placebo at the other operation. A number of subjective and objective assessments were made for paired comparison, including: pain, local temperature, swelling, post-operative bleeding, trismus, adverse effects, preference scores, wound healing, bone regeneration and laboratory examinations. The drug caused a significant reduction of post-operative pain, swelling and trismus. Global therapeutic effect and preference scores were highly in favour of the active drug. In the GP period, there was a statistically significant reduction in Hgb, RBC, lymphocytes and ESR, and an increase in neutrophils 3 days after the operation, compared to placebo. Individual values indicate a potentially clinically relevant effect of GP on Hgb and RBC. The clinical relevance of the changes in neutrophil and lymphocyte count, however, is questionable. The drug seemed to have no influence on the other laboratory parameters studied. Adverse effects occurred in 2 patients on GP and in 7 patients on placebo. The drug compares favourably with other NSAID tested in the same model.
D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D008297:Male; D010149:Postoperative Pain / Q000517:prevention & control; D010919:Placebos; D011183:Postoperative Complications / Q000517:prevention & control; D011897:Random Allocation; D013997:Time Factors; D014095:Tooth, Impacted / Q000601:surgery
D000893:Anti-Inflammatory Agents; D007093:Imidazoles; D010919:Placebos; C036844:2-tert-butyl-4(5)-phenyl-5(4)-(3-pyridyl)imidazole