Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain

Phase 3

Completed

Brief Summary: This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.

Detailed Description: Subjects will go through screening, an open-label conversion and titration phase of up to 6 weeks followed by an open-label treatment phase for up to 48 weeks with a 2 week follow-up period.

Recruitment & Eligibility

Inclusion Criteria

Subjects must have a diagnosed moderate to severe chronic pain condition treated with around-the-clock opioids for at least the past 3 months or in the Investigator's opinion qualify for around-the-clock opioid therapy for treatment of their pain
Subjects must have been taking opioids at least 5 days/week for the past month at an average daily dose of at least 30 mg hydrocodone
Subjects must be able to complete study procedures and attend clinic visits for 6 to 12 months
Females subjects of childbearing potential must have a negative urine pregnancy test at the Screen Visit, and must consent to use a medically-acceptable method of contraception throughout the entire study period.
Subjects must have had an adequate medical evaluation for the treatment of their underlying painful condition and appropriate primary medical/surgical therapies for the underlying condition
Subjects must voluntarily provide written informed consent

Exclusion Criteria

Any clinically significant condition that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of pain or increase the risk of opioid-related adverse events (AEs)
A medical condition that, in the opinion of the Investigator, would compromise the subject's ability to swallow, absorb, metabolize, or excrete study drug
A surgical procedure for pain within the last 3 months
Uncontrolled blood pressure, i.e., a sitting systolic blood pressure >180 mm Hg or <90 mm Hg, and/or a sitting diastolic blood pressure >120 mm Hg or <50 mm Hg at Screening
A body mass index (BMI) > 45 kg/m2
A hospital anxiety and depression scale (HADS) score of >12 in either depression or anxiety subscales or an established history of any psychiatric disorder that is poorly controlled
A clinically significant abnormality in clinical chemistry, hematology or urinalysis

Arm && Interventions

Group	Intervention	Description
Hydrocodone Bitartrate	Hydrocodone Bitartrate	Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.

Primary Outcome Measures

Name	Time	Method
Mean Change in Average Daily Pain	1 year	Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome.

Secondary Outcome Measures

Name	Time	Method
Maintenance of Efficacy	1 year	Clinic Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index, Hospital Anxiety and Depression Scale, Rescue Doses and Subject Global of Medication

Locations (50): Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
HOPE Research Institute, LLC
🇺🇸
Phoenix, Arizona, United States
Cochise Clinical Research
🇺🇸
Sierra Vista, Arizona, United States
Ortho Research
🇺🇸
Little Rock, Arkansas, United States
Pain Institute of California
🇺🇸
Bakersfield, California, United States
Providence Clinical Research
🇺🇸
Burbank, California, United States
South Orange County Surgical Medical Group
🇺🇸
Laguna Hills, California, United States
Scripps Clinic, Clinical Research
🇺🇸
San Diego, California, United States
Mountain View Clinical Research, Inc.
🇺🇸
Golden, Colorado, United States
Stamford Therapeutics Consortium
🇺🇸
Stamford, Connecticut, United States
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Arizona Research Center
🇺🇸Phoenix, Arizona, United States