Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT01452529|
Recruitment Status : Completed
First Posted : October 17, 2011
Results First Posted : December 4, 2014
Last Update Posted : June 28, 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. The sleep disturbance subscale comprised the responses to questions 1, 3, 7, and 8 on the assessment. The individual responses for each question were recorded on a 5-point scale with options ranging from 1 - "all of the time" to 5 - "none of the time". Sleep disturbance scores were transformed linearly on a scale of 0-100. A higher value indicates a better score; therefore, a higher score indicates a better 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: Baseline to 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: Baseline to 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452529
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