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
|ClinicalTrials.gov Identifier: NCT01358526|
Recruitment Status : Completed
First Posted : May 23, 2011
Results First Posted : September 3, 2014
Last Update Posted : November 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: Oxycodone/Naloxone Controlled-release Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1095 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||May 2011|
|Primary Completion Date :||October 2012|
|Study Completion Date :||November 2012|
Oxycodone/Naloxone Controlled-release Tablets (OXN)
Drug: Oxycodone/Naloxone Controlled-release
Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
Other Name: TARGINIQ ER
Placebo Comparator: Placebo
Placebo tablets to match OXN
Placebo tablets to match OXN taken orally every 12 hours
- 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.
- The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 [ Time Frame: 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) [ Time Frame: 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.
- Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline [ Time Frame: Week 12 ]A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period.
- Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline [ Time Frame: Week 12 ]A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358526
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