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Efficacy and safety of tramadol/acetaminophen tablets (Ultracet) as add-on therapy for osteoarthritis pain in subjects receiving a COX-2 nonsteroidal antiinflammatory drug: a multicenter, randomized, double-blind, placebo-controlled trial.
J Rheumatol. 2004 Jan; 31(1):150-6.JR

Abstract

OBJECTIVE

To evaluate the efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg combination tablets (tramadol/APAP) as add-on therapy for subjects with osteoarthritis (OA) pain inadequately controlled by COX-2 nonsteroidal antiinflammatory drugs (NSAID).

METHODS

This 91-day, multicenter, randomized, double-blind, placebo-controlled trial enrolled subjects with symptomatic OA for >/= 1 year who experienced at least moderate pain [visual analog scale (VAS) score >/= 50/100 mm] despite treatment with stable doses of celecoxib (>/= 200 mg/day) or rofecoxib (>/= 25 mg/day). Tramadol/APAP or matching placebo was titrated to 4 tablets/day on Day 10 and thereafter as needed up to 8 tablets/day. The primary efficacy measure was final VAS score; secondary measures included final pain relief rating scores, subject/investigator overall medication assessments, rate and time to discontinuation due to lack of efficacy, and selected quality-of-life/physical functioning scores.

RESULTS

Of 307 subjects randomized, 306 taking celecoxib (56.5%) or rofecoxib (43.5%) were included in the intent-to-treat population (n = 153 tramadol/APAP, 153 placebo). Mean final VAS scores for tramadol/APAP plus COX-2 NSAID were significantly lower than placebo plus COX-2 NSAID (41.5 vs 48.3; p = 0.025) and mean final pain relief rating scores were significantly higher (p = 0.002). Subjects taking tramadol/APAP showed significant improvements compared with placebo in subject/investigator medication assessments, as well as in the WOMAC Physical Function and the Medical Outcome Study Short Form-36 Role-Physical measures. The most common treatment-related adverse events for tramadol/APAP were somnolence (6.5%), nausea (4.6%), and constipation (3.3%). Mean tramadol/APAP dose was 4.1 tablets (154 mg tramadol/ 1332 mg APAP).

CONCLUSION

Tramadol 37.5 mg/APAP 325 mg combination tablets were effective and safe as add-on therapy with COX-2 NSAID for treatment of OA pain.

Authors+Show Affiliations

Radiant Research/Reading,Wyomissing, Pennsylvania 19610, USA. ronaldemkey@radiantresearch.comNo 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
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14705234

Citation

Emkey, Ronald, et al. "Efficacy and Safety of Tramadol/acetaminophen Tablets (Ultracet) as Add-on Therapy for Osteoarthritis Pain in Subjects Receiving a COX-2 Nonsteroidal Antiinflammatory Drug: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial." The Journal of Rheumatology, vol. 31, no. 1, 2004, pp. 150-6.
Emkey R, Rosenthal N, Wu SC, et al. Efficacy and safety of tramadol/acetaminophen tablets (Ultracet) as add-on therapy for osteoarthritis pain in subjects receiving a COX-2 nonsteroidal antiinflammatory drug: a multicenter, randomized, double-blind, placebo-controlled trial. J Rheumatol. 2004;31(1):150-6.
Emkey, R., Rosenthal, N., Wu, S. C., Jordan, D., & Kamin, M. (2004). Efficacy and safety of tramadol/acetaminophen tablets (Ultracet) as add-on therapy for osteoarthritis pain in subjects receiving a COX-2 nonsteroidal antiinflammatory drug: a multicenter, randomized, double-blind, placebo-controlled trial. The Journal of Rheumatology, 31(1), 150-6.
Emkey R, et al. Efficacy and Safety of Tramadol/acetaminophen Tablets (Ultracet) as Add-on Therapy for Osteoarthritis Pain in Subjects Receiving a COX-2 Nonsteroidal Antiinflammatory Drug: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial. J Rheumatol. 2004;31(1):150-6. PubMed PMID: 14705234.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of tramadol/acetaminophen tablets (Ultracet) as add-on therapy for osteoarthritis pain in subjects receiving a COX-2 nonsteroidal antiinflammatory drug: a multicenter, randomized, double-blind, placebo-controlled trial. AU - Emkey,Ronald, AU - Rosenthal,Norman, AU - Wu,Shu-Chen, AU - Jordan,Donna, AU - Kamin,Marc, AU - ,, PY - 2004/1/6/pubmed PY - 2004/4/28/medline PY - 2004/1/6/entrez SP - 150 EP - 6 JF - The Journal of rheumatology JO - J. Rheumatol. VL - 31 IS - 1 N2 - OBJECTIVE: To evaluate the efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg combination tablets (tramadol/APAP) as add-on therapy for subjects with osteoarthritis (OA) pain inadequately controlled by COX-2 nonsteroidal antiinflammatory drugs (NSAID). METHODS: This 91-day, multicenter, randomized, double-blind, placebo-controlled trial enrolled subjects with symptomatic OA for >/= 1 year who experienced at least moderate pain [visual analog scale (VAS) score >/= 50/100 mm] despite treatment with stable doses of celecoxib (>/= 200 mg/day) or rofecoxib (>/= 25 mg/day). Tramadol/APAP or matching placebo was titrated to 4 tablets/day on Day 10 and thereafter as needed up to 8 tablets/day. The primary efficacy measure was final VAS score; secondary measures included final pain relief rating scores, subject/investigator overall medication assessments, rate and time to discontinuation due to lack of efficacy, and selected quality-of-life/physical functioning scores. RESULTS: Of 307 subjects randomized, 306 taking celecoxib (56.5%) or rofecoxib (43.5%) were included in the intent-to-treat population (n = 153 tramadol/APAP, 153 placebo). Mean final VAS scores for tramadol/APAP plus COX-2 NSAID were significantly lower than placebo plus COX-2 NSAID (41.5 vs 48.3; p = 0.025) and mean final pain relief rating scores were significantly higher (p = 0.002). Subjects taking tramadol/APAP showed significant improvements compared with placebo in subject/investigator medication assessments, as well as in the WOMAC Physical Function and the Medical Outcome Study Short Form-36 Role-Physical measures. The most common treatment-related adverse events for tramadol/APAP were somnolence (6.5%), nausea (4.6%), and constipation (3.3%). Mean tramadol/APAP dose was 4.1 tablets (154 mg tramadol/ 1332 mg APAP). CONCLUSION: Tramadol 37.5 mg/APAP 325 mg combination tablets were effective and safe as add-on therapy with COX-2 NSAID for treatment of OA pain. SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/14705234/Efficacy_and_safety_of_tramadol/acetaminophen_tablets__Ultracet__as_add_on_therapy_for_osteoarthritis_pain_in_subjects_receiving_a_COX_2_nonsteroidal_antiinflammatory_drug:_a_multicenter_randomized_double_blind_placebo_controlled_trial_ L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&pmid=14705234 DB - PRIME DP - Unbound Medicine ER -