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
Study type: Interventional
Phase: Phase 3

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.
    

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.

      Participants entered the open label titration period and received hydrocodone ER tablets
      beginning with 15 mg every 12 hours for 3 to 7 days. The objective of the open label
      titration period was to find the successful dose of hydrocodone ER tablets that produced
      stable pain relief (defined as an Average Pain Intensity (API) score of 4 or less on the
      11-point numerical rating scale for either 3 consecutive days or 3 out of 5 consecutive days
      while the patient was maintained on the same dose of study drug for up to 7 days). Patients
      returned to the study center prior to each dose adjustment.

      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). Patients 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.
    

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
Intervention MeSH terms: Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; low back pain; Moderate to Severe Pain