scholarly journals A randomized, open-label study of once-a-day AVINZA® (morphine sulfate extended-release capsules) versus twice-a-day OxyContin® (oxycodone hydrochloride controlled-release tablets) for chronic low back pain: The extension phase of the ACTION trial

2006 ◽  
Vol 2 (6) ◽  
pp. 325 ◽  
Author(s):  
Richard L. Rauck, MD ◽  
Stephen A. Bookbinder, MD ◽  
Timothy R. Bunker, MD ◽  
Christopher D. Alftine, MD ◽  
Richard Ghalie, MD ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Extended Release ◽  
Extension Phase ◽  
Low Back ◽  
Open Label ◽  
Pain Scores ◽  
Evaluation Phase ◽  
Morphine Equivalent

Study design and objective: The ACTION ® trial, an open-label, randomized, multicenter, two-part study, compared the efficacy and safety of two sustained-release opioids (SROs), AVINZA (A-MQD), morphine sulfate extended-release capsules given once a day, and OxyContin® (O-ER), oxycodone modified-release tablets given twice a day, in subjects with chronic, moderate to severe low back pain. The first part of the study, the evaluation phase, was followed by an optional four-month extension phase aimed at evaluating the long-term stability of pain control, SRO dose, and quality of sleep.Results: Three hundred and ninety-two subjects were enrolled in the study; 220 completed the evaluation phase, and 174 entered the extension phase. During the latter phase, subjects in the A-MQD group (n = 79) continued to report lower pain scores, better quality of sleep, lower daily morphine-equivalent doses (means of 86 mg versus 119 mg), and a comparable usage of ibuprofen compared to subjects in the O-ER group (n = 95). The incidence and severity of elicited opioid side effects were similar between the two groups.Conclusions: Both study drugs resulted in significant pain relief and improved sleep in SRO-naive patients with chronic low back pain, and this outcome was attained with a stable daily SRO dose. In patients who completed opioid dose titration, AVINZA performed significantly better than OxyContin in reducing pain scores and improving sleep—with a lower morphine-equivalent daily dose—during both the evaluation and extension phases.

The ACTION study: A randomized, open-label, multicenter trial comparing once-a-day extended-release morphine sulfate capsules (AVINZA®) to twice-a-day controlled-release oxycodone hydrochloride tablets (OxyContin®) for the treatment of chronic, moderate to severe low back pain

2006 ◽  
Vol 2 (3) ◽  
pp. 155 ◽  
Author(s):  
Richard L. Rauck, MD ◽  
Stephen A. Bookbinder, MD ◽  
Timothy R. Bunker, MD ◽  
Christopher D. Alftine, MD ◽  
Richard Ghalie, MD ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Control ◽  
Extended Release ◽  
Morphine Sulfate ◽  
Dose Titration ◽  
Low Back ◽  
Open Label ◽  
Opioid Dose ◽  
Evaluation Phase

This large, open-label, randomized, parallel-group, multicenter study compared two oral sustained-release opioids (SROs)—AVINZA® (A-MQD), morphine sulfate extended-release capsules given once a day, and OxyContin® (O-ER), oxycodone modified-release tablets given twice a day—in SRO-naive subjects ages 30 to 70 with chronic, moderate to severe low back pain. Of the 392 subjects enrolled and randomized, 266 (132 in the AMQD group and 134 in the O-ER group) completed the opioid dose titration phase and entered an eight-week evaluation phase. During the evaluation phase, A-MQD achieved significantly better pain control than O-ER, as demonstrated by a greater decrease from baseline in pain scores obtained four times daily during weeks one, four, and eight (p = 0.002). The number of breakthrough-pain rescue medication doses adjusted for the number of patient days was significantly lower in the A-MQD group (p < 0.0001). Better pain control with A-MQD was achieved with a significantly lower daily opioid dose than with O-ER (mean 69.9 mg and 91 mg morphine equivalents, respectively; p = 0.0125). Quality of sleep was significantly better with A-MQD for the entire evaluation phase (p = 0.0026). The incidence and severity of elicited opioid side effects were similar in the two groups. This trial demonstrated that once-daily A-MQD provides consistent around-the-clock pain relief in patients with low back pain. In patients who completed opioid dose titration, A-MQD was significantly better than O-ER for reducing pain and improving sleep, while requiring a lower daily opioid dose.

Efficacy and safety of a hydrocodone extended-release tablet formulated with abuse-deterrence technology in patients with moderate-to-severe chronic low back pain

2015 ◽  
Vol 11 (6) ◽  
pp. 507 ◽  
Author(s):  
Martin E. Hale, MD ◽  
Thomas R. Zimmerman, MD ◽  
Eli Eyal, MSc ◽  
Richard Malamut, MD
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Extended Release ◽  
Study Drug ◽  
Low Back ◽  
Efficacy And Safety ◽  
Open Label ◽  
Double Blind ◽  
Drug Loss ◽  
Efficacy Measure

Objective: To evaluate efficacy and safety of hydrocodone bitartrate extended-release (ER) tablets developed with CIMA® Abuse-Deterrence Technology (ADT) versus placebo in alleviating moderate-to-severe pain in patients with chronic low back pain.Design: Phase 3, randomized, double-blind study consisting of a screening period (7-14 days), open-label titration period (≤6 weeks), and double-blind treatment period (≤12 weeks).Setting: Seventy-eight US centers.Main outcome measures: Changes from baseline at week 12 in weekly average of daily worst pain intensity (WPI; primary efficacy measure), weekly average pain intensity (API; secondary efficacy measure), adverse events (AEs), and study drug loss and diversion.Results: Patients (N = 625) who entered open-label dose titration and identified the analgesic hydrocodone ER dose (30-90 mg every 12 h) providing optimal pain relief with minimal AEs were randomized to hydrocodone ER (n = 191) or placebo (n = 180) for double-blind treatment at the identified dose; 297 patients completed the study. Least squares means [SE] changes from baseline were significantly greater (worsening pain; 11-point scale) with placebo than hydrocodone ER in weekly average of daily WPI (0.74 [0.15] vs 0.11 [0.14]; p < 0.001) and weekly API (0.55 [0.14] vs −0.03 [0.12]; p < 0.001). The most common AEs with hydrocodone ER were constipation (14 percent) and nausea (10 percent). Study drug loss (≤4 percent) and diversion (≤2 percent) rates were low.Conclusions: Hydrocodone ER formulated with ADT was significantly more effective than placebo in alleviating chronic low back pain and demonstrated a safety profile consistent with that of opioids, with a low occurrence of study drug loss and diversion.

Evaluation of quality of life following treatment with etoricoxib in patients with arthritis or low-back pain: an open label, uncontrolled pilot study in Mexico

2004 ◽  
Vol 20 (5) ◽  
pp. 691-698 ◽  
Author(s):  
Cesar R. Ramos-Remus ◽  
Elke Hunsche ◽  
Panagiotis Mavros ◽  
Julio Querol ◽  
Rafael Suarez ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Low Back Pain ◽  
Back Pain ◽  
Pilot Study ◽  
Low Back ◽  
Open Label

A randomized, open-label, multicenter trial comparing once-a-day AVINZA® (morphine sulfate extended-release capsules) versus twice-a-day OxyContin® (oxycodone hydrochloride controlled-release tablets) for the treatment of chronic, moderate to severe low back pain: Improved physical functioning in the ACTION trial

2007 ◽  
Vol 3 (1) ◽  
pp. 35 ◽  
Author(s):  
Richard L. Rauck, MD ◽  
Stephen A. Bookbinder, MD ◽  
Timothy R. Bunker, MD ◽  
Christopher D. Alftine, MD ◽  
Steven Gershon, MD ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Physical Functioning ◽  
Mental Component Summary ◽  
Extended Release ◽  
Bodily Pain ◽  
Multicenter Trial ◽  
Low Back ◽  
Once Daily ◽  
Evaluation Phase

This multicenter trial compared the efficacy, safety, and effect on quality of life and work limitation of once-daily extended-release morphine sulfate capsules (AVINZA9, A-MQD) and twice-daily controlled-release oxycodone HCl tablets (OxyContin9, O-ER) in subjects with chronic, moderate to severe low back pain. After randomization and a period of opioid dose titration, subjects (n = 266) underwent an eight-week evaluation phase and an optional four-month extension phase (n = 174 in extension phase). Subjects were assessed using the 12-item Short-Form Health Survey9 (SF-12) and the Work Limitations Questionnaire9 (WLQ). In both groups, significant improvements were observed in the SF-12 mean scores for physical functioning (p < 0.001), role physical (p < 0.0001), bodily pain (p < 0.0001), physical summary (p < 0.001), and mental component summary (p < 0.005). At the end of the titration period, greater relative improvements from baseline were seen in the SF-12 section on physical components in the A-MQD group versus the O-ER group, with significant differences observed for physical functioning (p = 0.0374), role physical (p = 0.0341), bodily pain (p = 0.0001), and physical summary (p = 0.0022). In both groups, SF-12 mean scores improved significantly for mental health (p < 0.01), role emotional (p < 0.01), social functioning (p < 0.0005), vitality (p < 0.005), and the mental component summary (p < 0.005), but no significant differences were noted between the two groups. Both groups reported improvement from baseline in WLQ physical demands scores, with no significant differences noted between the two groups. At the end of the evaluation phase, fewer subjects were unable to work due to illness or treatment in the A-MQD group than in the OER group (8.5percent versus 19.4percent, respectively; p = 0.0149). In conclusion, compared to twice-daily OxyContin, once-daily AVINZA resulted in significantly better and earlier improvement of physical function and ability to work.

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