drugset / Trial / NCT01685684
Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic low back pain requiring around-the-clock opioid analgesia for an extended period of time.
Timeline
- Start
- 2012-08
- Primary completion
- 2014-06
- Completion
- 2014-07
Outcome
Met primary endpoint
registry analysis (unspecified test); Oxycodone DETERx (Double-blind Maintenance Phase) vs Placebo (Double-blind Maintenance Phase); p <0.0001; Marginal Mean Difference (Net) -1.56; z-test NCT01685684 ↗
release “met the primary efficacy endpoint by showing that patients with chronic low back pain treated with Oxycodone DETERx ® experienced a statistically significant reduction in pain” collegiumpharma.com ↗
Publications
- Results Katz N, Kopecky EA, O'Connor M, Brown RH, Fleming AB. A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain. Pain. 2015 Dec;156(12):2458-2467. doi: 10.1097/j.pain.0000000000000315.
- Kopecky EA, Vaughn B, Lagasse S, O'Connor M. Tolerability, Safety, and Effectiveness of Oxycodone DETERx in Elderly Patients >/=65 Years of Age with Chronic Low Back Pain: A Randomized Controlled Trial. Drugs Aging. 2017 Aug;34(8):603-613. doi: 10.1007/s40266-017-0473-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxycodone | Other / unclassified | 40 mg | — |
| Subject | Oxycodone | Other / unclassified | 160 mg | — |