Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain

Curr Med Res Opin. 2010 Oct;26(10):2375-84. doi: 10.1185/03007995.2010.515478.


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.

Research design and 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.

Clinical trial registration: NCT00375934.

Main outcome measure: 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.

Conclusion: 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Capsules
  • Diclofenac / administration & dosage*
  • Diclofenac / adverse effects
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Gelatin
  • Hallux Valgus / drug therapy
  • Hallux Valgus / surgery*
  • Humans
  • Male
  • Metatarsal Bones / surgery
  • Middle Aged
  • Orthopedics / methods
  • Pain, Postoperative / drug therapy*
  • Placebos
  • Young Adult


  • Anti-Inflammatory Agents, Non-Steroidal
  • Capsules
  • Placebos
  • Diclofenac
  • Gelatin

Associated data

  • ClinicalTrials.gov/NCT00375934