Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 625.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: chronic low back pain; hydrocodone bitartrate; opioids

Summary:

      The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate
      extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in
      alleviating moderate to severe pain in patients with chronic low back pain. Patients may be
      opioid-naïve or opioid-experienced.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has had moderate to severe chronic low back pain for at least 3 months
             duration before screening.

          -  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 is willing and able to successfully self-administer the study drug, comply
             with study restrictions, complete the electronic diary, and return to the study center
             for scheduled study visits, as specified in the protocol.

          -  The patient is 18 through 80 years of age at the time of screening.

          -  Women of childbearing potential (not surgically sterile or 2 years postmenopausal)
             must use a medically accepted method of contraception, 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. - Acceptable methods of contraception
             include barrier method with spermicide, intrauterine device (IUD), or steroidal
             contraceptive (oral, transdermal, implanted, and injected) in conjunction with a
             barrier method. NOTE: A woman will be considered surgically sterile if she has had a
             tubal ligation, hysterectomy, bilateral salpingo-oophorectomy or bilateral
             oophorectomy, or hysterectomy with bilateral salpingo-oophorectomy.

          -  Other criteria apply.

        Exclusion Criteria:

          -  The patient is taking a total of more than 135 mg/day of oxycodone, or equivalent,
             during the 14 days before screening.

          -  The patient's primary painful condition under study is related to any source of
             chronic pain other than low back pain.

          -  The patient has radicular (nerve compression) pain or another type of purely
             neuropathic pain.

          -  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.

          -  The patient has medical or psychiatric disease that, in the opinion of the
             investigator, would compromise collected data.

          -  Other criteria apply.