A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain.

Abstract

OBJECTIVES:

This multicenter, randomized, double-blind, placebo-controlled study with an enriched enrollment, randomized withdrawal design was conducted to evaluate the analgesic efficacy and safety of single-entity, once-daily hydrocodone 20 to 120 mg tablets (HYD) in opioid-naive and opioid-experienced patients with uncontrolled moderate to severe chronic low back pain (CLBP).

RESEARCH DESIGN AND METHODS:

The primary endpoint was week 12 pain intensity scores (11-point scale, 0 = no pain) using a mixed effect model with repeated measures incorporating a pattern mixture model framework. Responder analysis was a secondary endpoint. Safety was assessed.

RESULTS:

Out of 905 patients who were treated with HYD during the open-label titration period, 588 (65%) were randomized to continue to receive HYD (n = 296, 20 - 120 mg taken once daily, average daily dose 57 mg) or a matching placebo (n = 292). HYD demonstrated superior pain reduction (p = 0.0016); this result was supported by sensitivity analyses using different approaches to handling missing data. Proportions of patients achieving ≥ 30 and ≥ 50% improvement in pain from screening to week 12 also favored HYD (p = 0.0033 and 0.0225, respectively). HYD was generally well tolerated.

CONCLUSIONS:

HYD was shown to be an efficacious treatment for CLBP in this study. There were no new or unexpected safety concerns detected.

• Authors: Warren Wen, Steve Sitar, Shau Yu Lynch, Ellie He, Steven R Ripa
• Journal: Expert opinion on pharmacotherapy (Expert Opin Pharmacother) Vol. 16 Issue 11 Pg. 1593-606 ( 2015) ISSN: 1744-7666 [Electronic] England
• PMID: 26111544 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Opioid
• Tablets
• Hydrocodone

Topics

• Adult
• Analgesics, Opioid (adverse effects, therapeutic use)
• Chronic Disease
• Double-Blind Method
• Female
• Humans
• Hydrocodone (adverse effects, therapeutic use)
• Low Back Pain (drug therapy, physiopathology)
• Male
• Middle Aged
• Tablets
• Treatment Outcome