Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Hydrocodone Bitartrate
Intervention description: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks
Intervention MeSH terms: Hydrocodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 424.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: chronic pain

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.
    

Eligibility criteria:

        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