A Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Enriched Study Design to Assess the Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Pain Due to Chronic Low Back Pain Who Require Around-the-clock Opioid Therapy

Purdue Pharma LP142 sites in 1 country1,095 target enrollmentMay 2011

ConditionsLow Back Pain

InterventionsOxycodone/Naloxone Controlled-release Placebo

DrugsOxycodone/Naloxone Controlled-release Placebo

Overview

Phase: Phase 3
Intervention: Oxycodone/Naloxone Controlled-release
Conditions: Low Back Pain
Sponsor: Purdue Pharma LP
Enrollment: 1095
Locations: 142
Primary Endpoint: The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid therapy.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

November 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Purdue Pharma LP

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

OXN

Oxycodone/Naloxone Controlled-release Tablets (OXN)

Intervention: Oxycodone/Naloxone Controlled-release

Placebo

Placebo tablets to match OXN

Intervention: Placebo

Outcomes

Primary Outcomes

The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period

Time Frame: 24 hours (Week 12)

The "average pain over the last 24 hours" score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.