title: Two placebo-controlled, randomized withdrawal studies to evaluate the fentanyl 1 day patch in opioid-naïve patients with chronic pain.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of fentanyl 1 day patch in opioid-naïve patients with non-cancer chronic pain insufficiently relieved by non-opioid analgesics.
  
  
  METHODS
  Two phase III placebo-controlled, double-blind, group-comparison, randomized withdrawal studies were conducted in patients with osteoarthritis and/or low back pain (N01 study) and post-herpetic neuralgia, complex regional pain syndrome, or chronic postoperative pain (N02) in Japan. Both studies consisted of period I (10-29 days of titration, fentanyl 12.5-50.0 µg/h) and period II (12 weeks double-blind).
  
  
  BACKGROUND
  N01, NCT01008618; N02, NCT01008553 MAIN OUTCOME MEASURES: The primary endpoint was the number of days until study discontinuation due to insufficient pain relief in period II, and secondary endpoints included pain scored on visual analog scale (VAS), subject's overall assessment, the number of rescue dose, brief pain inventory short form score, score on short-form 36-item health survey version 2.0, physician's overall assessment, and assessment of adverse events.
  
  
  RESULTS
  Of the 218 (N01) and 258 (N02) subjects who entered period I, 150 and 163 subjects entered period II, respectively. In the N01 study, the between-group difference was significant in the VAS score (95% CI: 7.3 [1.1, 13.5] mm, P = 0.0215) but not in the primary endpoint (P = 0.0846, log-rank test). In the N02 study, both primary efficacy (P = 0.0003) and VAS (8.7 [2.4, 15.0] mm, P = 0.0071) results showed that fentanyl was more effective than placebo. The major adverse events were nervous system and gastrointestinal disorders typically associated with opioid analgesic use. The incidence of adverse events in the fentanyl group was 68.5% to 85.7%.
  
  
  CONCLUSIONS
  Although the primary efficacy results showed significant effects of fentanyl in the N02 but not the N01 study, overall results showed that fentanyl 1 day patch is effective and well tolerated.
authors.affiliation: a Janssen Pharmaceutical KK , Tokyo , Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Arai
authors.affiliation: a Janssen Pharmaceutical KK , Tokyo , Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Kashimoto
authors.affiliation: a Janssen Pharmaceutical KK , Tokyo , Japan.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Ukyo
authors.affiliation: a Janssen Pharmaceutical KK , Tokyo , Japan.
authors.forename: Yushin
authors.initials: Y
authors.lastname: Tominaga
authors.affiliation: a Janssen Pharmaceutical KK , Tokyo , Japan.
authors.forename: Keiichiro
authors.initials: K
authors.lastname: Imanaka
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D059350:Chronic Pain / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage*; D006801:Humans; D007564:Japan; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl
keywords: 1 day patch; Chronic pain; Fentanyl; Opioid