Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain
|ClinicalTrials.gov Identifier: NCT01452529|
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : December 4, 2014
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Drug: Hydrocodone bitartrate q24h film-coated tablets Drug: Placebo to match hydrocodone bitartrate q24h tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||905 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Run-in to Assess the Efficacy and Safety of Hydrocodone Bitartrate (HYD) Tablets 20 to 120 mg Once-daily in Subjects With Moderate to Severe Chronic Low Back Pain|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Hydrocodone bitartrate
Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Drug: Hydrocodone bitartrate q24h film-coated tablets
Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily
Other Name: Hysingla ER
Placebo Comparator: Placebo
Placebo to match hydrocodone bitartrate once daily tablets
Drug: Placebo to match hydrocodone bitartrate q24h tablets
Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily
- Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score [ Time Frame: Week 12 ]Mean pain intensity for "average pain over the last 24 hours" score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine).
- Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale [ Time Frame: Weeks 4, 8, and 12 ]The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep. It includes a sleep problems index and 6 subscales - sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. A higher value indicates a better score; therefore, a positive change from screening indicates a better sleep pattern and a negative change from screening indicates a worsening in sleep pattern.
- Patient Global Impression of Change (PGIC) [ Time Frame: Week 12 ]The PGIC is an ordinal scale which assesses 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 "very much improved" and "much improved" was summarized by treatment group.
- 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 mean pain intensity at 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 mean pain intensity at week 12 of the double-blind period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452529
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