Francis Clark

Premier Research Group, Philadelphia, Pennsylvania, United States

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Publications (5)7.12 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC; Zipsor*) is a novel formulation of diclofenac potassium used to treat mild to moderate acute pain. To investigate whether DPSGC 25 mg provided significant reduction in pain intensity compared with placebo, regardless of baseline pain intensity, a post hoc analysis was performed of pooled data from two replicate randomized controlled trials (NCT00366444 and NCT00375934) that evaluated the safety and efficacy of DPSGC in postbunionectomy treatment. Patients from the two randomized trials were assigned to one of two subgroups: patients with baseline numerical pain rating scale (NPRS) scores of 4 or greater to less than 7 and those with baseline NPRS scores of 7 or greater. Within each subgroup, efficacy and safety of DPSGC was compared with placebo. Across the two studies, 73 DPSGC- and 59 placebo-treated patients had baseline pain intensity scores ranging from 4 or greater to less than 7, while 128 DPSGC- and 141 placebo-treated patients had baseline pain intensity scores of 7 or greater. Significantly lower mean 48-hour NPRS scores were observed in the DPSGC group, regardless of baseline pain intensity (P < 0.0001). In both subgroups, at least twice as many patients treated with DPSGC rated the study drug as very good or excellent compared with patients taking placebo. Potential limitations for this post hoc analysis include study design and patient population. As with all studies investigating treatment for pain, the use of rescue medication may also be a potential limitation. DPSGC provided significantly greater improvements in pain compared with placebo following bunionectomy, regardless of patients' baseline pain level.
    Current Medical Research and Opinion 05/2012; 28(6):953-61. · 2.37 Impact Factor
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    ABSTRACT: To evaluate the efficacy and safety of two dose strengths of oxycodone hydrochloride (HCl)/niacin tablets * for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery. Randomized, double-blind, placebo-controlled, US multicenter, repeat-dose study (Clinicaltrials.gov: NCT00654069). A total of 606 patients aged ≥18 years with moderate-to-severe pain post-bunionectomy were screened, and 405 patients were randomized to receive placebo, 2 × 5/30 mg oxycodone HCl/niacin tablets, or 2 × 7.5/30 mg oxycodone HCl/niacin tablets administered every 6 hours for 48 hours. Ketorolac tromethamine was available as rescue medication. Primary efficacy endpoint was the sum of pain-intensity difference scores during the 48 hours (SPID(48)) following the initial dose of study drug. Secondary efficacy endpoints included a responder analysis and use of rescue medication. Safety evaluations included adverse events (AEs), vital signs, and clinical laboratory assessments. Both doses of oxycodone HCl/niacin tablets demonstrated superior reductions in pain intensity compared with placebo as evidenced by the SPID(48) (p < 0.0001 for both oxycodone HCl/niacin 2 × 5/30 mg and 2 × 7.5/30 mg). AEs were consistent with the known effects of oxycodone HCl and niacin. Most AEs were mild or moderate in intensity, and no serious AEs occurred. There were no discontinuations due to AEs in the placebo group; 2/135 (1.5%) discontinued due to AEs in the 2 × 5/30 mg group and 4/134 (3.0%) in the 2 × 7.5/30 mg group. A limitation of this study was that there was no active comparator arm. Oxycodone HCl/niacin tablets (5/30 mg and 7.5/30 mg) provide effective analgesia and are generally well tolerated in patients with moderate-to-severe pain following bunionectomy surgery.
    Current Medical Research and Opinion 03/2011; 27(3):593-603. · 2.37 Impact Factor
  • Source
    Journal of Pain - J PAIN. 01/2011; 12(4).
  • [Show abstract] [Hide abstract]
    ABSTRACT: 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. 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. NCT00375934. The primary efficacy endpoint was the average NPRS score over the 48 hour inpatient multiple-dose period. 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. 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.
    Current Medical Research and Opinion 10/2010; 26(10):2375-84. · 2.37 Impact Factor
  • Journal of Pain - J PAIN. 01/2009; 10(4).

Publication Stats

16 Citations
7.12 Total Impact Points

Institutions

  • 2011
    • Premier Research Group
      Philadelphia, Pennsylvania, United States
  • 2010
    • Weil Foot and Ankle Institute
      Chicago, Illinois, United States