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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The study consisted of a screening period of approximately 7 to 14 days, an open label
      titration period of up to 6 weeks, and a double blind treatment period of 12 weeks.

      The objective of the open label titration period was to find the successful dose of
      hydrocodone extended release (ER) tablets that produced stable pain relief without
      unacceptable adverse events (AEs). Stable pain relief was defined as an average pain
      intensity (API) score over the previous 24 hours of 4 or less and a worst pain intensity
      (WPI) score of 6 or less on the 11-point numerical rating scale (NRS-11) (0=no pain to
      10=worst pain imaginable) for either 4 consecutive days or 4 out of 7 consecutive days, while
      the same dose of study drug was maintained for up to 7 days. Scores for WPI and API were
      recorded daily in individual patient electronic diaries. Patients returned to the study
      center prior to each dose adjustment.

      The starting dose of hydrocodone ER tablets depended on whether the subject was opioid-naïve
      or opioid-experienced. Opioid-naïve participants started at a 15-mg dose of hydrocodone ER
      tablets every 12 hours. For opioid-experienced participants, the starting dose of hydrocodone
      ER tablets was to be approximately equivalent to 50% of the dose of opioid analgesic that
      they were receiving at screening and administered every 12 hours. Investigators switched
      participants from previous opioid therapy to hydrocodone ER tablets on the basis of
      predefined dose equivalents.

      Participants who met the criterion of a stabilized dose were randomly assigned into the 12
      week, double-blind, placebo controlled treatment period on the final day of the open label
      titration period (baseline visit). Participants began treatment with double blind study drug
      at the effective dose of hydrocodone ER tablets achieved during the titration period or
      matching placebo. Rescue medication was permitted in addition to the study drug during the
      double blind treatment period.

      Participants who participated in the study in compliance with the protocol and complete 12
      weeks of double-blind treatment with study drug, were considered to have completed the study
      and could have been eligible to enroll in a 6-month open-label study (study C32337/3104,
      NCT01922739).
    

Intervention name(s): Hydrocodone ER; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): CEP-33237; Hydrocodone bitartrate extended-release tablets
Intervention MeSH terms: Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic low back pain; hydrocodone bitartrate; opioids