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

Author(s): Daniels SE, Baum DR, Clark F, Golf MH, McDonnell ME, Boesing SE

Affiliation(s): Premier Research Group, Ltd, Austin, TX 78666, USA. Stephen.Daniels@premier-research.com

Publication date & source: 2010-10, Curr Med Res Opin., 26(10):2375-84.

Publication type: Research Support, Non-U.S. Gov't

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.

Page last updated: 2010-10-05

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