Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain; Low Back Pain
Intervention: Placebo; Hydrocodone bitartrate
Intervention description: Capsules, no active substance, shells identical to active comparator capsules; dosage form: capsule
Strengths 10mg, 20mg, 30mg, 40mg, 50mg
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: 510.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: chronic pain; back pain

Summary:

      The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate
      controlled-release capsules in subjects with chronic low back pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a clinical diagnosis of moderate to severe chronic lower back pain
             (CLBP)

          -  Subjects must be classified as non-neuropathic, neuropathic, or symptomatic for more
             than 6 months after lower back pain (LBP) surgery

          -  Subjects must in the Investigator's opinion qualify for around-the-clock opioid
             therapy for treatment of their chronic lower back pain (CLBP).

          -  Subjects must have been taking opioids for at least 5 days/week for the past 4weeks

          -  Subjects must have an average Clinic Pain Score of ≥ 4 on the 11-point (0-10) numeric
             rating scale (NRS) as an average for the last 24 hours of Screening

          -  Subjects, in the opinion of the Investigator, must be considered to be in generally
             good health other then CLBP at Screening

          -  Female subjects of childbearing potential must have a negative urine pregnancy test at
             the Screening Visit, and must consent to use a medically-acceptable method of
             contraception throughout the entire study period.

          -  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 and other
             symptoms of CLBP or increase the risk of opioid-related adverse events

          -  A medical condition that, in the opinion of the Investigator, would compromise the
             subject's ability to swallow, absorb, metabolize, or excrete the study drug

          -  A surgical procedure for back pain within 6 months

          -  A nerve or plexus block, including epidural steroid injections or facet blocks

          -  A history of chemotherapy or confirmed malignancy within past 2 years

          -  Any other chronic pain condition other than CLBP that, in the Investigator's opinion,
             would interfere with the assessment of LBP e.g. fibromyalgia, osteoarthritis,
             rheumatoid arthritis, migraine headaches requiring opioid treatment

          -  Uncontrolled blood pressure, i.e., subject has a sitting systolic blood pressure >180
             mmHg or <90 mmHg, and/or a sitting diastolic blood pressure >120 mmHg or <50 mmHg at
             Screening

          -  A Body Mass Index (BMI) >45 kg/m2

          -  A Hospital Anxiety and Depression Scale (HADS) Index score of >12 in either depression
             or anxiety subscales or an established history of major depressive disorder that is
             poorly controlled with medication

          -  A clinically significant abnormality in clinical chemistry, hematology or urinalysis