The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.
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Participants With Adverse Experiences
Timeframe: Day 1 of open-label titration period - Week 52 of the open-label treatment period
Participants With Potentially Clinically Significant (PCS) Abnormal Laboratory Values During the Open-Label Treatment Period by Participant Status
Timeframe: Day 1 - Week 52 of the open-label treatment period
Participants With Potentially Clinically Significant Abnormal Vital Signs Values by Participant Status
Timeframe: Day 1 of open-label titration period - Week 52 of the open-label treatment period
Shifts in Electrocardiogram (ECG) Findings From Baseline to Overall Study by Participant Status
Timeframe: Baseline for new participants was between Day -7 and -14 (the study 3080 screening visit); baseline for rollover participants was the last ECG in study 3079. During study ECGs were performed on weeks 24 and 52 of the open-label treatment period
Participants With Clinically Significant (CS) Hearing Changes From Baseline in Pure Tone Audiometry Test Results by Patient Status
Timeframe: Baseline for new participants was between Day -7 and -14 (study 3080 screening visit); baseline for rollover participants was the baseline test in study 3079. During study covers both open-label titration and 52-week treatment periods