Abstract | OBJECTIVE: RESEARCH DESIGN AND METHODS: This was a double-blind, randomized, two-part study of 252 patients with moderate-to-severe pain the day after first metatarsal bunionectomy. Patients were treated with a single dose of rofecoxib 50 mg (N = 85), enteric-coated diclofenac sodium 100 mg (N = 85), or placebo (N = 82) on study Day 1 (Part I), and subsequently with daily rofecoxib 50 mg or placebo ( diclofenac patients switched to placebo) over study Days 2-5 (Part II). Patients rated their pain at 16 time points over the first 24 h. Primary endpoint was total pain relief over 8 h (TOPAR8). Pre-specified secondary endpoints on Day 1 included onset of analgesia, peak pain relief, and duration of response. For Part II, supplemental analgesia use with rofecoxib compared to placebo was pre-specified for analysis over Days 2-5, with the focus on Days 2-3. Adverse experiences were recorded over Days 1-5. RESULTS: For TOPAR8 scores, rofecoxib 50 mg was significantly more effective than placebo (9.5 vs. 3.7, p < 0.001) and diclofenac (9.5 vs. 5.0, p < 0.001). Onset of analgesia was more rapid with rofecoxib than placebo (p = 0.003) and diclofenac (p = 0.019); proportion of patients achieving onset within 4 h with rofecoxib, diclofenac, and placebo was 46%, 27%, and 23%, respectively. Peak pain relief was greater with rofecoxib (1.8) than diclofenac (1.2, p = 0.004) and placebo (1.0, p < 0.001). Diclofenac and placebo patients required supplemental analgesia sooner than rofecoxib patients (2:03 h vs. 4:02 h, p < 0.001 and 1:41 h vs. 4:02 h, p < 0.001). Rofecoxib patients used significantly less (p < 0.001) supplemental analgesia than placebo patients over Days 2-3 (1.1 tablets/day vs. 2.1 tablets/day) and Days 2-5 (0.9 tablets/day vs. 1.8 tablets/day). No significant differences in adverse experiences between treatments were seen. CONCLUSION:
Rofecoxib 50 mg was significantly more effective than placebo on all measures of treatment of post-bunionectomy pain. Rofecoxib 50 mg was significantly more effective than diclofenac sodium 100 mg based on Day 1 endpoints of total pain relief, onset time, and duration of response. All study medications were generally well tolerated.
|
Authors | Paul J Desjardins, Peter M Black, Steven Daniels, Steven R Bird, Brian J Fitzgerald, Richard A Petruschke, Andrew Tershakovec, David J Chang |
Journal | Current medical research and opinion
(Curr Med Res Opin)
Vol. 20
Issue 10
Pg. 1523-37
(Oct 2004)
ISSN: 0300-7995 [Print] England |
PMID | 15462686
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Lactones
- Placebos
- Sulfones
- rofecoxib
- Diclofenac
|
Topics |
- Administration, Oral
- Adult
- Anti-Inflammatory Agents, Non-Steroidal
(therapeutic use)
- Diclofenac
(therapeutic use)
- Double-Blind Method
- Female
- Hallux Valgus
(surgery)
- Humans
- Lactones
(therapeutic use)
- Male
- Middle Aged
- Orthopedic Procedures
(adverse effects)
- Pain Measurement
- Pain, Postoperative
(drug therapy)
- Placebos
- Sulfones
(therapeutic use)
|