Efficacy and Safety of Hydrocodone Bitartrate (HYD) in Subjects With Moderate to Severe Chronic Low Back Pain

Phase 3

Completed

Conditions: Chronic Low Back Pain

Interventions: Drug: Hydrocodone bitartrate q24h film-coated tablets
Drug: Placebo to match hydrocodone bitartrate q24h tablets

Registration Number: NCT01452529

Lead Sponsor: Purdue Pharma LP

Brief Summary: The primary objective of this study is to evaluate the analgesic efficacy and safety of HYD tablets 20 to 120 mg once-daily dose compared to placebo in subjects with moderate to severe chronic low back pain uncontrolled by their current stable analgesic regimen

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 905

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrocodone bitartrate	Hydrocodone bitartrate q24h film-coated tablets	Hydrocodone bitartrate (HYD) once daily (q24h) tablets
Placebo	Placebo to match hydrocodone bitartrate q24h tablets	Placebo to match hydrocodone bitartrate once daily tablets

Primary Outcome Measures

Name	Time	Method
Mean Pain Intensity for "Average Pain Over the Last 24 Hours" Score	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).

Secondary Outcome Measures

Name	Time	Method
Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale	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)	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 ≥ 50% Reduction in Pain Compared to Baseline	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 ≥ 30% Reduction in Pain Compared to Baseline	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.

Trial Locations

Locations (98): Alliance Clinical Research
🇺🇸
Birmingham, Alabama, United States
Coastal Clinical Research, Inc.
🇺🇸
Mobile, Alabama, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Redpoint Research
🇺🇸
Tucson, Arizona, United States
Genova Clinical Research
🇺🇸
Tucson, Arizona, United States
Quality of Life Medical & Research Center, LLC
🇺🇸
Tucson, Arizona, United States
ACRI-Phase 1, LLC
🇺🇸
Anaheim, California, United States
Orange County Research Institute
🇺🇸
Anaheim, California, United States
United Clinical Research Center, Inc.
🇺🇸
Anaheim, California, United States
Research Center of Fresno, Inc.
🇺🇸
Fresno, California, United States
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Alliance Clinical Research
🇺🇸Birmingham, Alabama, United States