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Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of postoperative pain: a double-blind, placebo- and active-controlled parallel-group study.
Clin Ther. 2004 Dec; 26(12):2003-14.CT

Abstract

OBJECTIVE

This study compared the efficacy and safety of a single dose of oxycodone 5 mg/ibuprofen 400 mg versus its individual components and placebo in a third-molar extraction model.

METHODS

In this multicenter, double-blind, double-dummy, parallel-group investigation, subjects with moderate to severe pain within 5 hours after extraction of > or =2 ipsilateral bony impacted third molars were randomized to single doses of oxycodone 5 mg/ibuprofen 400 mg, ibuprofen 400 mg, oxycodone 5 mg, or placebo. Primary efficacy variables were the sum of pain intensity difference over 6 hours (SP1D6) and total pain relief through 6 hours (TOTPAR6). The pharmacokinetics of oxycodone and ibuprofen, alone and in combination, were also determined in a subset of patients.

RESULTS

A total of 498 subjects were randomized to treatment (187 to oxycodone 5 mg/ibuprofen 400 mg, 186 to ibuprofen 400 mg, 63 to oxycodone 5 mg, and 62 to placebo). Baseline demographics were generally similar among treatment groups, despite differences in sex (P = 0.041) and race (P = 0.023). Combination therapy was associated with greater analgesia than ibuprofen alone, oxycodone alone, or placebo (mean [SE] TOTPAR6: 13.3 [0.52], 12.2 [0.52], 4.3 [0.82], and 4.2 [0.83], respectively [P < 0.001 vs oxycodone or placebo, P = 0.012 vs ibuprofen]; mean [SE] SP1D6: 6.54 [0.42], 5.41 [0.44], 0.14 [0.60], and 0.32 [0.59], respectively [P < 0.001 vs oxycodone or placebo, P = 0.002 vs ibuprofen]). Combination therapy was well tolerated. Pharmacokinetic results implied no interaction between oxycodone and ibuprofen.

CONCLUSIONS

In this study, a single dose of oxycodone 5 mg/ibuprofen 400 mg was fast-acting, effective, and well tolerated in subjects with moderate to severe pain after dental surgery. Oxycodone 5 mg alone did not provide an efficacy benefit over placebo in this study.

Authors+Show Affiliations

Goldman School of Dental Medicine, Boston University, 100 East Newton Street, Rm. 107, Boston, MA 02118, USA. tvandyke@bu.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

15823764

Citation

Van Dyke, Thomas, et al. "Combination Oxycodone 5 Mg/ibuprofen 400 Mg for the Treatment of Postoperative Pain: a Double-blind, Placebo- and Active-controlled Parallel-group Study." Clinical Therapeutics, vol. 26, no. 12, 2004, pp. 2003-14.
Van Dyke T, Litkowski LJ, Kiersch TA, et al. Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of postoperative pain: a double-blind, placebo- and active-controlled parallel-group study. Clin Ther. 2004;26(12):2003-14.
Van Dyke, T., Litkowski, L. J., Kiersch, T. A., Zarringhalam, N. M., Zheng, H., & Newman, K. (2004). Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of postoperative pain: a double-blind, placebo- and active-controlled parallel-group study. Clinical Therapeutics, 26(12), 2003-14.
Van Dyke T, et al. Combination Oxycodone 5 Mg/ibuprofen 400 Mg for the Treatment of Postoperative Pain: a Double-blind, Placebo- and Active-controlled Parallel-group Study. Clin Ther. 2004;26(12):2003-14. PubMed PMID: 15823764.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of postoperative pain: a double-blind, placebo- and active-controlled parallel-group study. AU - Van Dyke,Thomas, AU - Litkowski,Leonard J, AU - Kiersch,Theodore A, AU - Zarringhalam,Nooshin Majd, AU - Zheng,Hongjie, AU - Newman,Kenneth, PY - 2004/11/08/accepted PY - 2005/4/13/pubmed PY - 2005/4/29/medline PY - 2005/4/13/entrez SP - 2003 EP - 14 JF - Clinical therapeutics JO - Clin Ther VL - 26 IS - 12 N2 - OBJECTIVE: This study compared the efficacy and safety of a single dose of oxycodone 5 mg/ibuprofen 400 mg versus its individual components and placebo in a third-molar extraction model. METHODS: In this multicenter, double-blind, double-dummy, parallel-group investigation, subjects with moderate to severe pain within 5 hours after extraction of > or =2 ipsilateral bony impacted third molars were randomized to single doses of oxycodone 5 mg/ibuprofen 400 mg, ibuprofen 400 mg, oxycodone 5 mg, or placebo. Primary efficacy variables were the sum of pain intensity difference over 6 hours (SP1D6) and total pain relief through 6 hours (TOTPAR6). The pharmacokinetics of oxycodone and ibuprofen, alone and in combination, were also determined in a subset of patients. RESULTS: A total of 498 subjects were randomized to treatment (187 to oxycodone 5 mg/ibuprofen 400 mg, 186 to ibuprofen 400 mg, 63 to oxycodone 5 mg, and 62 to placebo). Baseline demographics were generally similar among treatment groups, despite differences in sex (P = 0.041) and race (P = 0.023). Combination therapy was associated with greater analgesia than ibuprofen alone, oxycodone alone, or placebo (mean [SE] TOTPAR6: 13.3 [0.52], 12.2 [0.52], 4.3 [0.82], and 4.2 [0.83], respectively [P < 0.001 vs oxycodone or placebo, P = 0.012 vs ibuprofen]; mean [SE] SP1D6: 6.54 [0.42], 5.41 [0.44], 0.14 [0.60], and 0.32 [0.59], respectively [P < 0.001 vs oxycodone or placebo, P = 0.002 vs ibuprofen]). Combination therapy was well tolerated. Pharmacokinetic results implied no interaction between oxycodone and ibuprofen. CONCLUSIONS: In this study, a single dose of oxycodone 5 mg/ibuprofen 400 mg was fast-acting, effective, and well tolerated in subjects with moderate to severe pain after dental surgery. Oxycodone 5 mg alone did not provide an efficacy benefit over placebo in this study. SN - 0149-2918 UR - https://www.unboundmedicine.com/medline/citation/15823764/Combination_oxycodone_5_mg/ibuprofen_400_mg_for_the_treatment_of_postoperative_pain:_a_double_blind_placebo__and_active_controlled_parallel_group_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(04)00072-4 DB - PRIME DP - Unbound Medicine ER -