NCT01240863

A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 15 to 90 mg Every 12 Hours 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

Completed Phase 3 Results posted Last updated 2 June 2017

What this trial tests

Phase 3 trial testing Hydrocodone ER in Chronic Pain in 391 participants. Completed in 1 August 2011.

Timeline

1 November 2010

Primary endpoint
1 August 2011

1 August 2011

Quick facts

Lead sponsor	Teva Branded Pharmaceutical Products R&D, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	391
Start date	1 November 2010
Primary completion	1 August 2011
Estimated completion	1 August 2011
Sites	73 locations across United States

Drugs / interventions tested

• Hydrocodone ER — full drug profile →
• Placebo

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. — full company profile →

Who can join

Adults 18 to 80, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline to Week 12 in Weekly Average Pain Intensity (wAPI)
  Time frame: Baseline (end of Open-Label Titration Period), Week 12 of Double-blind Treatment Period
  The primary efficacy variable was the change from baseline to week 12 in the wAPI. The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The Week 12 wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the succ

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmaceutical therapeutics for articular regeneration and restoration: state-of-the-art technology for screening small molecular drugs.
   Chen Y, Sun H, Yao X, Yu Y, et al · · 2021 · cited 9× · PMID 34783870 · DOI 10.1007/s00018-021-03983-8
2. Efficacy and tolerability of a hydrocodone extended-release tablet formulated with abuse-deterrence technology for the treatment of moderate-to-severe chronic pain in patients with osteoarthritis or low back pain.
   Hale ME, Laudadio C, Yang R, Narayana A, et al · · 2015 · cited 9× · PMID 26396543 · DOI 10.2147/jpr.s83930