NCT01789970

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) at 30 to 90 mg Every 12 Hours for Relief of Moderate to Severe Pain in Patients With Chronic 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 Low Back Pain in 625 participants. Completed in 1 February 2014.

Timeline

1 March 2013

Primary endpoint
1 February 2014

1 February 2014

Quick facts

Lead sponsor	Teva Branded Pharmaceutical Products R&D, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	625
Start date	1 March 2013
Primary completion	1 February 2014
Estimated completion	1 February 2014
Sites	87 locations across United States

Drugs / interventions tested

• Hydrocodone ER — full drug profile →
• Placebo

Conditions studied

• Low Back Pain — all drugs for Low Back Pain →

Sponsor

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

Who can join

Adults 18 to 80, any sex, with Low Back 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 of the Treatment Period in Weekly Average of Daily Worst Pain Intensity (WPI)
  Time frame: Days -6 to 0 of Treatment Period (baseline), Week 12 of Treatment Period
  The WPI was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described their worst pain intensity over the last 24 hours. Weekly WPI scores averaged daily scores collected over the previous 7 days for each analysis visit. Negati

Sponsor's own description

The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in alleviating moderate to severe pain in patients with chronic low back pain. Patients may be opioid-naïve or opioid-experienced.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Opioids compared to placebo or other treatments for chronic low-back pain.
   Chaparro LE, Furlan AD, Deshpande A, Mailis-Gagnon A, et al · · 2013 · cited 135× · PMID 23983011 · DOI 10.1002/14651858.cd004959.pub4