Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

Phase 3

Completed

• Conditions: Low Back Pain
• Interventions: Drug: Oxycodone/Naloxone Controlled-release; Drug: Placebo

• Registration Number: NCT01358526
• Lead Sponsor: Purdue Pharma LP

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-23
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Results First Submitted: 2014-07-29
• Results First Submitted QC: 2014-08-21
• Results First Posted: 2014-09-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1095

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OXN	Oxycodone/Naloxone Controlled-release	Oxycodone/Naloxone Controlled-release Tablets (OXN)
Placebo	Placebo	Placebo tablets to match OXN

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12	Weeks 4, 8, and 12	The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance.
Patient Global Impression of Change (PGIC)	Week 12	The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding "much improved" and "very much improved" was summarized by treatment group and compared between groups using an exact test.

Trial Locations

Locations (142)

Alabama Orthopaedic Center, PC; 🇺🇸 Birmingham, Alabama, United States

Alliance Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Winston Technology Research, LLC; 🇺🇸 Haleyville, Alabama, United States

Monte Sano Clinical Research, LLC; 🇺🇸 Huntsville, Alabama, United States

Research Facility; 🇺🇸 Bountiful, Utah, United States

Radiant Research, Inc.; 🇺🇸 Chandler, Arizona, United States

Dedicated Clinical Research; 🇺🇸 Phoenix, Arizona, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Clinical Research Advantage, Inc./Tatum Highlands Medical Associates, PLLC; 🇺🇸 Phoenix, Arizona, United States

Quality of Life Medical & Research Center, LLC; 🇺🇸 Tucson, Arizona, United States

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