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.

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: Ronald Emkey, Norman Rosenthal, Shu-Chen Wu, Donna Jordan, Marc Kamin, CAPSS-114 Study Group
• Journal: The Journal of rheumatology (J Rheumatol) Vol. 31 Issue 1 Pg. 150-6 (Jan 2004) ISSN: 0315-162X [Print] Canada
• PMID: 14705234 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Cyclooxygenase Inhibitors
• Drug Combinations
• Lactones
• Narcotics
• Placebos
• Pyrazoles
• Sulfonamides
• Sulfones
• Ultracet
• rofecoxib
• Acetaminophen
• Tramadol
• Celecoxib

Topics

• Acetaminophen (administration & dosage, adverse effects)
• Aged
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects)
• Celecoxib
• Cyclooxygenase Inhibitors (administration & dosage)
• Double-Blind Method
• Drug Combinations
• Female
• Humans
• Lactones (administration & dosage)
• Male
• Middle Aged
• Narcotics (administration & dosage, adverse effects)
• Osteoarthritis (drug therapy)
• Pain (drug therapy)
• Placebos
• Pyrazoles
• Sulfonamides (administration & dosage)
• Sulfones
• Tramadol (administration & dosage, adverse effects)
• Treatment Outcome