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Expert Opin Pharmacother. 2015;16(11):1593-606. doi: 10.1517/14656566.2015.1060221. Epub 2015 Jun 26.

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.

Author information

1
Medical Research, Purdue Pharma L.P. , One Stamford Forum, Stamford, CT 06901 , USA +1 203 588 7631 ; +1 203 588 7423 ; Warren.Wen@pharma.com.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01452529.

KEYWORDS:

chronic low back pain; hydrocodone; opioid; randomized controlled trial

PMID:
26111544
DOI:
10.1517/14656566.2015.1060221
[Indexed for MEDLINE]

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