A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics

Hye Suk Han, Ki Hyeong Lee, Kyung Hee Lee, Jeong Seon Ryu, Young Chul Kim, Seung Woo Park, Ho Suk Oh, Kyung Tae Park, Jung Hye Kwon, Pyung Bok Lee, Won Sik Lee, Yang Soo Kim, Joong Bae Ahn, Seong Woo Jeon, Sung Yong Lee, Young Mi Seol, Jung Hun Kang, Young Jin Yuh, So Yeon Oh, Suk Ran KimJin Seok Ahn

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Purpose: 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.

Original languageEnglish
Pages (from-to)741-750
Number of pages10
JournalSupportive Care in Cancer
Volume22
Issue number3
DOIs
Publication statusPublished - 2014 Jan 1

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Hydromorphone
Multicenter Studies
Analgesics
Pain
Sleep
Pain Management
Cancer Pain
Opioid Analgesics
Quality of Life

Keywords

  • Analgesics
  • Cancer
  • Hydromorphone
  • Opioid
  • Pain

ASJC Scopus subject areas

  • Oncology

Cite this

A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics. / Han, Hye Suk; Lee, Ki Hyeong; Lee, Kyung Hee; Ryu, Jeong Seon; Kim, Young Chul; Park, Seung Woo; Oh, Ho Suk; Park, Kyung Tae; Kwon, Jung Hye; Lee, Pyung Bok; Lee, Won Sik; Kim, Yang Soo; Ahn, Joong Bae; Jeon, Seong Woo; Lee, Sung Yong; Seol, Young Mi; Kang, Jung Hun; Yuh, Young Jin; Oh, So Yeon; Kim, Suk Ran; Ahn, Jin Seok.

In: Supportive Care in Cancer, Vol. 22, No. 3, 01.01.2014, p. 741-750.

Research output: Contribution to journalArticle

Han, HS, Lee, KH, Lee, KH, Ryu, JS, Kim, YC, Park, SW, Oh, HS, Park, KT, Kwon, JH, Lee, PB, Lee, WS, Kim, YS, Ahn, JB, Jeon, SW, Lee, SY, Seol, YM, Kang, JH, Yuh, YJ, Oh, SY, Kim, SR & Ahn, JS 2014, 'A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics', Supportive Care in Cancer, vol. 22, no. 3, pp. 741-750. https://doi.org/10.1007/s00520-013-2030-1
Han, Hye Suk ; Lee, Ki Hyeong ; Lee, Kyung Hee ; Ryu, Jeong Seon ; Kim, Young Chul ; Park, Seung Woo ; Oh, Ho Suk ; Park, Kyung Tae ; Kwon, Jung Hye ; Lee, Pyung Bok ; Lee, Won Sik ; Kim, Yang Soo ; Ahn, Joong Bae ; Jeon, Seong Woo ; Lee, Sung Yong ; Seol, Young Mi ; Kang, Jung Hun ; Yuh, Young Jin ; Oh, So Yeon ; Kim, Suk Ran ; Ahn, Jin Seok. / A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics. In: Supportive Care in Cancer. 2014 ; Vol. 22, No. 3. pp. 741-750.
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T1 - A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics

AU - Han, Hye Suk

AU - Lee, Ki Hyeong

AU - Lee, Kyung Hee

AU - Ryu, Jeong Seon

AU - Kim, Young Chul

AU - Park, Seung Woo

AU - Oh, Ho Suk

AU - Park, Kyung Tae

AU - Kwon, Jung Hye

AU - Lee, Pyung Bok

AU - Lee, Won Sik

AU - Kim, Yang Soo

AU - Ahn, Joong Bae

AU - Jeon, Seong Woo

AU - Lee, Sung Yong

AU - Seol, Young Mi

AU - Kang, Jung Hun

AU - Yuh, Young Jin

AU - Oh, So Yeon

AU - Kim, Suk Ran

AU - Ahn, Jin Seok

PY - 2014/1/1

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N2 - Purpose: 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.

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KW - Analgesics

KW - Cancer

KW - Hydromorphone

KW - Opioid

KW - Pain

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