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Endo Pharmaceuticals (ENDP) Presents New Phase 2 Data Evaluating the Safety and Effectiveness of XIAFLEX (Collagenase Clostridium Histolyticum) for Dupuytren's Disease Nodules
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In a Phase 2, randomized, double-blind, placebo-controlled, dose-ranging study, in 75 adult study participants with Dupuytren's disease and at least 1 nodule who received a single injection of CCH 0.40 mg or 0.60 mg, a statistically significant decrease was shown from baseline in the mean nodule surface area (P≤0.001), consistency score (P<0.001) and hardness score (P≤0.01) at week 8 versus study participants receiving placebo. The safety profile of those treated with CCH was generally well tolerated. Adverse events included extremity pain, axillary pain, injection site-related adverse events and pruritus. One adverse event was reported as severe (injection site pain with CCH 0.60 mg). No patients were discontinued from the study because of an adverse event.The majority of study participants receiving higher doses of CCH were satisfied with their treatment and outcomes – 88.9 percent of 18 study participants in the 0.40 mg CCH group and 83.3 percent of 18 study participants in the 0.60 mg CCH group were "very satisfied" or "quite satisfied" with treatment at week 8 compared to placebo. Similarly, the investigators' global assessment showed an improvement in study participants versus placebo.
In this eight-week, double-blind trial, palpable palmar nodules on 75 adults with Dupuytren's disease and at least 1 palmar nodule were selected for treatment. Study participants were randomized to receive CCH 0.25 mg (n=22), 0.40 mg, or 0.60 mg (n=18, respectively) and then allocated to active treatment (CCH) or placebo (n=16). A single injection into the selected nodule was performed on Day 1. Starting at Week 1, all study participants were instructed to massage the nodule twice daily until Week 4. Efficacy and safety assessments were conducted throughout the study. Investigator-reported nodular consistency and hardness were evaluated at Weeks 1, 4, and 8. Investigator-rated patient improvement (1 [very much improved] to 7 [very much worse]) and patient satisfaction (1 [very satisfied] to 5 [very dissatisfied]) were assessed at week 8.
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Sep 30, 2016
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Related Keywords Xiaflex, Collagenase Clostridium Histolyticum, Dupuytren's Disease Nodules