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Lower Back Pain
August 29, 2011
Zogenix released results from a phase III trial of Zohydro (extended release hydrocodone bitartrate) for the treatment of chronic pain. This US-based, randomized, double blind, placebo controlled trial enrolled approximately 600 subjects with chronic low back pain and inadequate pain relief from their existing therapy. The subjects received Zohydro capsules (20-100 mg) or placebo every 12 hours. The primary endpoint was the mean change from baseline to the end of 12 weeks of treatment in the average 24-hour pain intensity ratings based on the 0-10 Numerical Rating Scale. Zohydro resulted in significantly (p≡0.008) improved chronic pain relief compared to placebo. The two key secondary endpoints were also met: the proportion of subjects with at least 30% improvement in pain intensity and the improvement of overall satisfaction of medication.
March 30, 2009
NeuroMed issued positive results from a phase III trial of Exalgo for the treatment of chronic pain. This US-based, randomized withdrawal, placebo-controlled, double-blind trial enrolled 268 opioid-tolerant subjects with chronic moderate to severe low back pain. The subjects received placebo or Exalgo at doses between 12 mg and 64 mg. The primary endpoint was the mean change from baseline to week 12 in pain intensity, assessed by an 11 point Likert Numerical Rating Scale (NRS). The study showed statistically significant results in the specified primary efficacy endpoint (p<0.0001). Results from multiple secondary efficacy endpoints were consistent with the primary efficacy endpoint. The overall safety profile and reported adverse events in the study were consistent with that of other opioids.
January 21, 2002
Phase III trial results indicate that Biovail's extended release tramadol formulation (Tramadol ER) produces statistically significant dose-related reductions in chronic low back pain. The trial included an open label run-in phase to identify subjects for continuation in a double-blind phase. At the beginning of the double-blind treatment phase, approximately 380 eligible subjects were randomly assigned to receive Tramadol ER 300 mg, Tramadol ER 200 mg or placebo. At the first time point evaluated (Week 1), Tramadol ER was statistically superior to placebo in reducing pain, with the Tramadol ER 300 mg dose demonstrating more effectiveness than the 200 mg dose. The effects of Tramadol ER were sustained over the 12-week duration of the double-blind phase.