Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain.
OBJECTIVE
Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) is a rapidly absorbed formulation of diclofenac approved for the treatment of mild to moderate acute pain in adults (≥18 years of age). The objective of this study was to investigate the efficacy and safety of DPSGC 25 mg in a multicenter, randomized, double-blind, placebo-controlled study in patients experiencing pain following first metatarsal bunionectomy.


METHODS
Patients experiencing a requisite level of pain (≥4 based on an 11-point numeric pain rating scale [NPRS]; 0 = no pain, 10 = worst pain possible) on the day following surgery were randomized to receive DPSGC 25 mg or placebo. Patients received a second dose (remedication) on request or at 8 hours postdose followed by additional doses every 6 hours through the end of postsurgery Day 4. Rescue medication (hydrocodone/acetaminophen) was available as needed after the second dose.


BACKGROUND
NCT00375934.


METHODS
The primary efficacy endpoint was the average NPRS score over the 48 hour inpatient multiple-dose period.


RESULTS
DPSGC provided a significant improvement in mean 48 hour NPRS scores over placebo (3.29 vs 5.74, respectively; p < 0.0001), as well as for summed pain intensity difference (203.1 vs 86.6; p < 0.0001). Patients treated with DPSGC experienced a faster onset of meaningful pain relief compared with placebo (p = 0.0034). Rescue medication use on Day 1 and Day 2 was reduced in the DPSGC group compared with placebo (53.5% vs 92.1% on Day 1; 30.3% vs 67.3% on Day 2; p < 0.0001). DPSGC was well tolerated and no patients treated with DPSGC reported serious adverse events. As with any study, there are potential limitations including study design and patient population.


CONCLUSIONS
These results indicate that DPSGC reduced pain in patients who underwent bunionectomy and this novel formulation of diclofenac potassium may be a practical option for treating mild to moderate acute pain.
Daniels
Stephen E
SE
Premier Research Group, Ltd, Austin, TX 78666, USA. Stephen.Daniels@premier-research.com
Baum
Douglas R
DR
Clark
Francis
F
Golf
Michael H
MH
McDonnell
Mark E
ME
Boesing
Stephen E
SE
D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects; D002214:Capsules; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005780:Gelatin; D006215:Hallux Valgus / Q000188:drug therapy / Q000601:surgery*; D006801:Humans; D008297:Male; D008682:Metatarsal Bones / Q000601:surgery; D008875:Middle Aged; D009985:Orthopedics / Q000379:methods; D010149:Postoperative Pain / Q000188:drug therapy*; D010919:Placebos; D055815:Young Adult
D000894:Anti-Inflammatory Agents, Non-Steroidal; D002214:Capsules; D010919:Placebos; D004008:Diclofenac; D005780:Gelatin