Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Hydrocodone ER
Intervention description: Hydrocodone bitartrate extended-release tablets were administered at doses of 15, 30, 45, 60, and 90 mg orally every 12 hours. During the open-label titration period, doses were adjusted until a stable pain control was achieved. In general, the dose of hydrocodone extended release tablets could be adjusted for efficacy or tolerability, as necessary, at any time during the open-label treatment period; however, participants were required to visit the study center before increasing the dose of study drug.
Intervention MeSH terms: Hydrocodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 330.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: moderate to severe pain; diabetic peripheral neuropathy; postherpetic neuralgia; traumatic injury; complex regional pain syndrome; back pain; neck pain; osteoarthritis; rheumatoid arthritis

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient must be willing and able to successfully self-administer the study drug,
             comply with study restrictions, and return to the clinic for scheduled study visits as
             specified in this protocol.

          -  The patient has either completed Cephalon study 3079 or has chronic pain of at least 3
             months duration prior to entering this study associated with any of the following
             conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury,
             complex regional pain syndrome, back pain, neck pain, osteoarthritis, or rheumatoid
             arthritis. Patients with other painful conditions may qualify for the study with
             permission from the Cephalon medical monitor or designee.

          -  Those patients who completed the 12-week, double-blind, placebo-controlled, randomized
             study (study 3079) and are willing to re-titrate study drug to an effective dose of
             hydrocodone extended-release tablets are eligible to enter this study.

          -  The patient is able to speak English, willing to provide written informed consent, and
             sign a written opioid agreement, to participate in this study.

          -  The patient is 18 through 80 years of age (inclusive) at the time of entering this or
             the previous study (study 3079).

          -  Women of childbearing potential (not surgically sterile or 2 years postmenopausal),
             must use a medically accepted method of contraception and must agree to continue use
             of this method for the duration of the study and for 30 days after participation in
             the study, and have a negative pregnancy test at screening.

        Exclusion Criteria:

          -  Patients who were enrolled in study 3079 but did not complete the 12-week,
             double-blind, placebo-controlled, randomized study may not be enrolled into this
             study.

          -  The patient has known or suspected hypersensitivities, allergies, or other
             contraindications to the study drug or its excipients.

          -  The patient has a recent history (within 5 years) or current evidence of alcohol or
             other substance abuse.

          -  The patient has a medical or psychiatric condition/disease that, in the opinion of the
             investigator, would compromise collected data.

          -  The patient is taking a total (i.e., including around-the clock [ATC] and rescue
             medications) of more than 135 mg/day of oxycodone or equivalent for 14 days prior to
             screening.

          -  The patient has a history of suicidality.

          -  The patient has a diagnosis of chronic headache or migraine as the primary painful
             condition under study.

          -  The patient is expected to have surgery during the study and it is anticipated that
             the surgery will alleviate the patient's pain.

          -  The patient is pregnant or lactating.

          -  The patient has active malignancy.

          -  The patient has human immunodeficiency virus (HIV).

          -  In the judgment of the investigator, the patient has any clinically significant
             deviation from normal in the physical examination and/or clinical laboratory test
             values.

          -  The patient has cardiopulmonary disease that would, in the opinion of the
             investigator, significantly increase the risk of treatment with potent synthetic
             opioids.

          -  The patient has participated in a study involving an investigational drug in the
             previous 30 days (excluding those who participated in study 3079).

          -  The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before
             the first treatment with study drug.

          -  The patient has any other medical condition or is receiving concomitant
             medication/therapy (e.g., regional nerve block) that would, in the opinion of the
             investigator, compromise the patient's safety or compliance with the study protocol,
             or compromise collected data.

          -  The patient is involved in active litigation in regard to the chronic pain currently
             being treated.

          -  The patient has a positive urine drug screen (UDS) for an illicit substance or
             medication not prescribed by the physician currently treating the chronic pain.

          -  The investigator feels that the patient is not suitable for the study.