Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time

Summary

The primary objective of this study is to evaluate efficacy of hydrocodone extended-release (ER) tablets compared with placebo in alleviating moderate to severe pain in patients with osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at week 12.

Timeline

Start

2010-11

Primary completion

2011-08

Completion

2011-08

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry p = 0.134; Mean Difference (Final Values) 0.35 (95% CI -0.11 to 0.82) reads as missed primary endpoint NCT01240863 ↗

release “The results showed significant improvement in the treatment of patients’ chronic low back pain” reads as met primary endpoint tevapharm.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydrocodone ER	Unknown	15 mg	—
Subject	Hydrocodone ER	Unknown	30 mg	—
Subject	Hydrocodone ER	Unknown	45 mg	—
Subject	Hydrocodone ER	Unknown	60 mg	—
Subject	Hydrocodone ER	Unknown	90 mg	—

Indications