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Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial.
J Rheumatol. 2004 Dec; 31(12):2454-63.JR

Abstract

OBJECTIVE

To evaluate the analgesic efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg (tramadol/APAP) combination tablets for treatment of chronic low back pain (LBP).

METHODS

This 91 day, multicenter, outpatient, randomized, double blind, placebo controlled study enrolled 338 patients with chronic LBP requiring daily medication for > or = 3 months. Patients with at least moderate pain [pain visual analog scale (VAS) with scores > or = 40/100 mm] after washout were randomized to tramadol/APAP or placebo. After a 10 day titration, patients received 1 or 2 tablets QID. Primary outcome measure was final pain VAS score. Secondary measures included pain relief, quality of life and physical functioning, efficacy failure, and overall medication assessments.

RESULTS

In total, 336 intent-to-treat patients received tramadol/APAP (n = 167) or placebo (n = 169). Mean baseline pain VAS score was 67.8. Intent-to-treat analysis showed significantly better mean final pain VAS scores (47.4 vs 62.9; p < 0.001) and mean final pain relief scores (1.8 vs 0.7; p < 0.001) for tramadol/APAP than for placebo. Roland Disability Questionnaire scores and physical-related subcategories of the McGill Pain Questionnaire and the Medical Outcome Study Short Form-36 Health Survey were significantly better for tramadol/APAP patients. More patients rated tramadol/APAP as "very good" or "good" than placebo (63.6 vs 25.2%; p < 0.001). Kaplan-Meier estimates of cumulative discontinuation rates due to efficacy failures were 22.9% (tramadol/APAP) vs 54.7% (placebo; p < 0.001). The most common treatment related adverse events with tramadol/APAP were nausea (12.0%), dizziness (10.8%), and constipation (10.2%). Average daily dose of tramadol/APAP was 4.2 tablets (tramadol 158 mg/APAP 1369 mg).

CONCLUSION

Tramadol 37.5 mg/APAP 325 mg combination tablets show efficacy in pain reduction, in measures of physical functioning and quality of life, and in overall medication assessments, with a tolerability profile comparable with other opioids used for the treatment of chronic LBP.

Authors+Show Affiliations

Division of Rheumatology, Roy and Lucille Carver College of Medicine, University of Iowa Health Care E330 GH, 200 Hawkins Drive, Iowa City, IA 52242, USA. ppeloso@adelphia.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15570651

Citation

Peloso, Paul M., et al. "Analgesic Efficacy and Safety of Tramadol/ Acetaminophen Combination Tablets (Ultracet) in Treatment of Chronic Low Back Pain: a Multicenter, Outpatient, Randomized, Double Blind, Placebo Controlled Trial." The Journal of Rheumatology, vol. 31, no. 12, 2004, pp. 2454-63.
Peloso PM, Fortin L, Beaulieu A, et al. Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial. J Rheumatol. 2004;31(12):2454-63.
Peloso, P. M., Fortin, L., Beaulieu, A., Kamin, M., & Rosenthal, N. (2004). Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial. The Journal of Rheumatology, 31(12), 2454-63.
Peloso PM, et al. Analgesic Efficacy and Safety of Tramadol/ Acetaminophen Combination Tablets (Ultracet) in Treatment of Chronic Low Back Pain: a Multicenter, Outpatient, Randomized, Double Blind, Placebo Controlled Trial. J Rheumatol. 2004;31(12):2454-63. PubMed PMID: 15570651.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial. AU - Peloso,Paul M, AU - Fortin,Luc, AU - Beaulieu,André, AU - Kamin,Marc, AU - Rosenthal,Norman, AU - ,, PY - 2004/12/1/pubmed PY - 2005/3/11/medline PY - 2004/12/1/entrez SP - 2454 EP - 63 JF - The Journal of rheumatology JO - J. Rheumatol. VL - 31 IS - 12 N2 - OBJECTIVE: To evaluate the analgesic efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg (tramadol/APAP) combination tablets for treatment of chronic low back pain (LBP). METHODS: This 91 day, multicenter, outpatient, randomized, double blind, placebo controlled study enrolled 338 patients with chronic LBP requiring daily medication for > or = 3 months. Patients with at least moderate pain [pain visual analog scale (VAS) with scores > or = 40/100 mm] after washout were randomized to tramadol/APAP or placebo. After a 10 day titration, patients received 1 or 2 tablets QID. Primary outcome measure was final pain VAS score. Secondary measures included pain relief, quality of life and physical functioning, efficacy failure, and overall medication assessments. RESULTS: In total, 336 intent-to-treat patients received tramadol/APAP (n = 167) or placebo (n = 169). Mean baseline pain VAS score was 67.8. Intent-to-treat analysis showed significantly better mean final pain VAS scores (47.4 vs 62.9; p < 0.001) and mean final pain relief scores (1.8 vs 0.7; p < 0.001) for tramadol/APAP than for placebo. Roland Disability Questionnaire scores and physical-related subcategories of the McGill Pain Questionnaire and the Medical Outcome Study Short Form-36 Health Survey were significantly better for tramadol/APAP patients. More patients rated tramadol/APAP as "very good" or "good" than placebo (63.6 vs 25.2%; p < 0.001). Kaplan-Meier estimates of cumulative discontinuation rates due to efficacy failures were 22.9% (tramadol/APAP) vs 54.7% (placebo; p < 0.001). The most common treatment related adverse events with tramadol/APAP were nausea (12.0%), dizziness (10.8%), and constipation (10.2%). Average daily dose of tramadol/APAP was 4.2 tablets (tramadol 158 mg/APAP 1369 mg). CONCLUSION: Tramadol 37.5 mg/APAP 325 mg combination tablets show efficacy in pain reduction, in measures of physical functioning and quality of life, and in overall medication assessments, with a tolerability profile comparable with other opioids used for the treatment of chronic LBP. SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/15570651/Analgesic_efficacy_and_safety_of_tramadol/_acetaminophen_combination_tablets__Ultracet__in_treatment_of_chronic_low_back_pain:_a_multicenter_outpatient_randomized_double_blind_placebo_controlled_trial_ L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&amp;pmid=15570651 DB - PRIME DP - Unbound Medicine ER -