Long-term Safety of Once-daily Hydrocodone Bitartrate (HYD) Tablets For Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain. Includes a 24-week Extension Period.
Condition: Chronic Nonmalignant and Nonneuropathic Pain
Intervention: Hydrocodone bitartrate q24h film-coated tablets
Intervention description: Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily
Intervention MeSH terms: Hydrocodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 922.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Nonmalignant pain; Nonneuropathic Pain; Opioid

Summary:

      The primary objective of this study is to characterize the long-term safety of Hydrocodone
      Bitartrate (HYD) tablets 20 to 120 mg once-daily in subjects with chronic nonmalignant and
      nonneuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria include:

          -  Male and female subjects ≥ 18 years of age with moderate to severe, chronic
             nonmalignant and nonneuropathic pain (lasting several hours daily) as their
             predominant pain condition for at least 3 months prior to the screening visit;

          -  Subjects deemed by the investigator/medically qualified designee (must be MD or DO) to
             be appropriate candidates for the protocol specified, around the clock HYD therapeutic
             regimen;

          -  Female subjects who are premenopausal or postmenopausal less than 1 year and who have
             not had surgical sterilization (ie, tubal ligation, partial or complete hysterectomy)
             must have a negative serum pregnancy test, be nonlactating, and willing to use
             adequate and reliable contraception throughout the study (eg, barrier with additional
             spermicidal foam or jelly, intra-uterine device, hormonal contraception);

          -  Subjects who are willing and able to be compliant with the protocol, are capable of
             subjective evaluation (ie pain scores), are able to read and understand
             questionnaires, are willing and able to use an electronic diary, and are able to read,
             understand, and sign the written informed consent form in English.

        Exclusion Criteria include:

          -  Subjects taking opioid analgesic(s) equivalent to > 120 mg/day of oxycodone during the
             14 days prior to the screening visit;

          -  Subjects who previously participated in an investigational hydrocodone study within 90
             days prior to the first dose of study medication ;

          -  Subjects who have used any investigational medication other than hydrocodone within 30
             days prior to the first dose of study drug;

          -  Subjects with any history of seizures (subjects with history of pediatric febrile
             seizures may participate in the study) or increase in intracranial pressure;

          -  Subjects with current uncontrolled depression or other uncontrolled psychiatric
             disorder (subjects with controlled depression or other psychiatric disorder must be on
             a stable medication for ≥ 1 month prior to the screening visit to participate in the
             study);

          -  Subjects with a history of alcohol, medication, or illicit drug abuse or addiction
             and/or history of opioid abuse or addiction at any time;

          -  Subjects with clinically unstable cardiac disease, including: unstable atrial
             fibrillation, symptomatic bradycardia, unstable congestive heart failure, active
             myocardial ischemia, or indwelling pacemaker;

          -  Subjects with unstable respiratory disease that, in the opinion of the investigator,
             precludes entry into this study;

          -  Subjects with biliary tract disease, hypothyroidism, adrenal cortical insufficiency,
             or any other medical condition that, in the opinion of the investigator, is
             inadequately treated and precludes entry into the study;

          -  Subjects with history of malignancy within past 2 years, with exception of basal cell
             carcinoma that has been successfully treated;

          -  Subjects with evidence of impaired liver function upon entry into the study
             (laboratory test values ≥ 3 times the upper limit of the laboratory reference (normal)
             range (ULN) for aspartate transaminase [AST/SGOT] or alanine transaminase [ALT/SGPT],
             or values > 2 times the ULN for alkaline phosphatase), or total bilirubin level > 1.5
             times the ULN or, in the opinion of the investigator/medically qualified designee
             (must be MD or DO), liver function impairment to the extent that the subject should
             not participate in this study;

          -  Subjects with evidence of impaired kidney function upon entry into the study (ie,
             serum creatinine ≥ 2.5 mg/dL);

          -  Subjects with any condition in which opioids are contraindicated, eg, severe
             respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive
             lung disease, cor pulmonale, severe bronchial asthma, or paralytic ileus;

          -  Subjects who are allergic to hydrocodone or who have a history of allergies to other
             opioids. This does not include subjects who have experienced common opioid side
             effects (eg, nausea, constipation);

          -  Subjects receiving monoamine oxidase inhibitors (MAOIs) or who have been taking MAOIs
             within 2 weeks of the screening visit.

        Other protocol-specific inclusion/exclusion criteria may apply.