Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time
Condition: Chronic Pain
MeSH terms: Osteoarthritis; Back Pain; Low Back Pain; Chronic Pain
Intervention: Hydrocodone ER; Placebo
Intervention description: During the open-label, titration period, all participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
Hydrocodone ER was taken by participants randomized to the hydrocodone ER treatment arm during the double-blind treatment period at the dose level identified during the titration period.
Participants were instructed to take tablets with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.; Placebo matching the active drug dose identified during the titration period was taken by participants randomized to the placebo treatment arm during the double-blind treatment period.
Participants were instructed to take intervention with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.
Intervention MeSH terms: Hydrocodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 391.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: osteoarthritis; low back pain; Moderate to Severe Pain

Summary:

      The primary objective of this study is to evaluate efficacy of hydrocodone extended-release
      (ER) tablets compared with placebo in alleviating moderate to severe pain in patients with
      osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at
      week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is able to speak English and is willing to provide written informed
             consent, including a written opioid agreement, to participate in this study.

          -  The patient must be willing and able to successfully self-administer the study drug,
             comply with study restrictions, complete the electronic diary, and return to the
             clinic for scheduled study visits as specified in this protocol.

          -  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.

          -  The patient has pain of at least 3 months' duration associated with osteoarthritis or
             low back pain.

          -  The patient reports an average pain intensity score, over the prior 24 hours, of 5 or
             more on the 11-point numerical rating scale.

          -  If the patient is receiving physical therapy, biofeedback therapy, acupuncture
             therapy, or herbal remedies, these therapies must remain unchanged during the study.

          -  The patient must not participate in other study involving an investigational agent
             while enrolled into the present study.

        Exclusion Criteria:

          -  The patient has known or suspected hypersensitivities, allergies, or other
             contraindications to any ingredient in the study drug.

          -  The patient has a recent history (within 5 years) or current evidence of alcohol or
             other substance abuse with the exception of nicotine or caffeine.

          -  The patient has medical or psychiatric disease that, in the opinion of the
             investigator, would compromise collected data.

          -  The patient is taking a total (ie, around-the-clock plus rescue medication) of more
             than 135 mg/day of oxycodone, or equivalent, during the 14 days prior to screening.

          -  The patient has a history of suicidality.

          -  The patient is expected to have surgery during the study.

          -  The patient's primary painful condition under study is related to any source of
             chronic pain other than osteoarthritis or low back 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 opioids.

          -  The patient has participated in a study involving an investigational drug in the
             previous 30 days.

          -  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 pain currently being
             treated.

          -  The patient has a positive urine drug screen (UDS) that is not medically explainable.

          -  The investigator feels that the patient is not suitable for the study for any reason.