title: A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics.
abstract: OBJECTIVE
  The objective of this study was to evaluate whether extended-release hydromorphone (osmotic-controlled release oral delivery system [OROS] hydromorphone) treatment provided pain relief in cancer patients whose pain was inadequately controlled by other analgesics.
  
  
  METHODS
  In this prospective, open-label, multicenter trial, patients who have sustained cancer pain with other analgesics were enrolled. After the baseline evaluation (visit 1), OROS hydromorphone was administered. Two evaluations (visits 2 and 3) were made: 29 ± 7 and 57 ± 7 days later, respectively. The primary end point was the pain intensity difference (PID) at visit 3 relative to visit 1 (expressed as percent PID).
  
  
  RESULTS
  In total, 879 patients were screened and 432 completed all three visits. Of the 874 full analysis set patients, 343 (39.2 %) improved by more than 30 % PID. Of the 432 per-protocol patients, 282 (65.3 %) improved by more than 30 % PID. At visits 2 and 3, the degree of sleep disturbance, the number of awakenings, and the degree of sleep satisfaction were significantly better than at visit 1 (all P < 0.0001 for both visit 1-visit 2 and visit 1-visit 3). However, this pain relief was not associated with improved quality of life (P = 0.326 and P = 0.055 for visit 1-visit 2 and visit 1-visit 3, respectively).
  
  
  CONCLUSIONS
  This study suggested that active pain management using the strong opioid OROS hydromorphone was beneficial in the management of cancer pain that was not controlled by other analgesics.
authors.affiliation: Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, South Korea.
authors.forename: Hye-Suk
authors.initials: HS
authors.lastname: Han
authors.forename: Ki Hyeong
authors.initials: KH
authors.lastname: Lee
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Lee
authors.forename: Jeong Seon
authors.initials: JS
authors.lastname: Ryu
authors.forename: Young Chul
authors.initials: YC
authors.lastname: Kim
authors.forename: Seung Woo
authors.initials: SW
authors.lastname: Park
authors.forename: Ho-Suk
authors.initials: HS
authors.lastname: Oh
authors.forename: Kyung Tae
authors.initials: KT
authors.lastname: Park
authors.forename: Jung Hye
authors.initials: JH
authors.lastname: Kwon
authors.forename: Pyung Bok
authors.initials: PB
authors.lastname: Lee
authors.forename: Won Sik
authors.initials: WS
authors.lastname: Lee
authors.forename: Yang Soo
authors.initials: YS
authors.lastname: Kim
authors.forename: Joong Bae
authors.initials: JB
authors.lastname: Ahn
authors.forename: Seong Woo
authors.initials: SW
authors.lastname: Jeon
authors.forename: Sung Yong
authors.initials: SY
authors.lastname: Lee
authors.forename: Young Mi
authors.initials: YM
authors.lastname: Seol
authors.forename: Jung Hun
authors.initials: JH
authors.lastname: Kang
authors.forename: Young Jin
authors.initials: YJ
authors.lastname: Yuh
authors.forename: So Yeon
authors.initials: SY
authors.lastname: Oh
authors.forename: Suk Ran
authors.initials: SR
authors.lastname: Kim
authors.forename: Jin Seok
authors.initials: JS
authors.lastname: Ahn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000627:therapeutic use*; D059390:Breakthrough Pain / Q000188:drug therapy* / Q000209:etiology; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D004091:Hydromorphone / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000453:epidemiology; D010147:Pain Measurement; D011446:Prospective Studies; D012890:Sleep; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D004091:Hydromorphone