Clinical Trials Resource Center

New Medical Therapies™

Lower Back Pain

August 18, 2014

Collegium Pharmaceutical issued results of a phase III study of Oxycodone DETERx for the treatment of patients with moderate-to- severe chronic low back pain. The phase III study was a multicenter, double-blind, enriched-enrollment, randomized-withdrawal, placebo-controlled study of Oxycodone DETERx versus placebo in opioid-experienced and opioid-naïve subjects with moderate-to-severe chronic low back pain. Patients who achieved a stable and effective dose of Oxycodone DETERx during the open-label titration phase were randomized (n=389) into the 12-week, double-blind maintenance phase, in which they either were maintained on their current dose regimen of Oxycodone DETERx or were tapered to placebo. The primary efficacy endpoint of the study was the change in average pain intensity from baseline to week 12; pain was measured using an 11-point pain intensity numerical rating scale (PI-NRS). The study met the primary efficacy endpoint, showing patients with chronic low back pain treated with Oxycodone DETERx experienced a statistically significant reduction in pain compared with placebo (p< 0.0001). The company is positioned to file an NDA with the FDA for Oxycodone DETERx by the end of 2014.

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.

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