Open Access(211) A Placebo‐Controlled Trial of Rofecoxib in the Treatment of Chronic Low Back Pain
Author(s) -
Ju William D.,
Krupa David A.,
Walters Donna J.,
Newman Todd L.,
Borenstein David G.,
Katz Nathaniel,
Group VIOXX® Chronic Low Back Pain Investigator
Publication year - 2001
Publication title -
pain medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.893
H-Index - 97
eISSN - 1526-4637
pISSN - 1526-2375
DOI - 10.1111/j.1526-4637.2001.pme01039-11.x
Subject(s) - rofecoxib , medicine , placebo , anesthesia , clinical endpoint , visual analogue scale , discontinuation , bedtime , analgesic , low back pain , randomized controlled trial , physical therapy , biochemistry , chemistry , alternative medicine , pathology , cyclooxygenase , enzyme
Objective: To evaluate the efficacy and safety of rofecoxib in the treatment of chronic low back pain. Study Design: Randomized, double‐blind, placebo‐controlled, parallel group, 4‐week, multicenter study. Patients: Individuals with chronic low back pain (Quebec Task Force on Spinal Disorders Class 1 and 2) who were routine users of analgesic medications for their back pain. Interventions: Patients meeting pain worsening (flare) criteria upon discontinuation of prestudy analgesics were randomized 1:1:1 to rofecoxib 25 mg (n = 126), rofecoxib 50 mg (n = 126), or placebo (n = 128), administered orally once daily. Results: Patient baseline characteristics were similar in all treatment groups (mean age 52.5 years, 63.2% female, mean duration of back pain 11.8 years, prestudy analgesics: NSAID 82.9 %, non‐NSAID 17.1%). Rofecoxib at both dose levels was superior to placebo as assessed by the Low Back Pain Intensity Scale (0‐ to 100‐mm VAS), the prespecified primary endpoint. The least square mean difference from placebo was −15.27 mm and −14.36 mm for the rofecoxib 25 mg and 50 mg dose levels, respectively (p < 0.001). Both rofecoxib regimens were superior to placebo in additional prespecified secondary and other endpoints: Bothersomeness Scale, Roland Morris Disability Questionnaire, Patient and Investigator Global Assessment of Response to Therapy, and Patient Global Assessment of Disease Status (p < 0.001 for all comparisons). As measured by the Relief from Starting Pain endpoint, rofecoxib 25 mg and 50 mg both achieved superiority to placebo by bedtime after the first morning dose (p < 0.001). For all endpoints, the 25 mg and 50 mg dose levels were not statistically different from each other. Rofecoxib in both regimens was generally well tolerated. Conclusions: Rofecoxib administered once daily reduced chronic low back pain and was well tolerated. The 25 mg and 50 mg regimens had similar efficacy.