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

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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.

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Acknowledgments

This research was supported by grants from the Janssen Pharmaceuticals whose role was restricted to providing assistance to the investigators in the conception, conduct, and analysis of this study.

Conflict of interest

We declare that no conflict of interest exists for any of the authors.

Author information

Authors and Affiliations

  1. Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, South Korea

    Hye-Suk Han & Ki Hyeong Lee

  2. Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, South Korea

    Kyung Hee Lee

  3. Department of Internal Medicine, Inha University College of Medicine, Incheon, South Korea

    Jeong Seon Ryu

  4. Department of Internal Medicine, Chonnam National University Hwasun Hospital, Gwangju, South Korea

    Young Chul Kim

  5. Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea

    Seung Woo Park & Joong Bae Ahn

  6. Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, South Korea

    Ho-Suk Oh

  7. Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea

    Kyung Tae Park

  8. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Seoul, South Korea

    Jung Hye Kwon

  9. Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea

    Pyung Bok Lee

  10. Department of Oncology/Hematology, Hwawon Jeil Internal Medicine Clinic, Daegu, South Korea

    Won Sik Lee

  11. Department of Internal Medicine, Gospel Hospital Kosin University College of Medicine, Busan, South Korea

    Yang Soo Kim

  12. Department of Internal Medicine, Kyungpook National University Medical Center, Daegu, South Korea

    Seong Woo Jeon

  13. Department of Internal Medicine, College of Medicine, Korea University, Seoul, South Korea

    Sung Yong Lee

  14. Department of Internal Medicine, School of Medicine, Pusan National University, Busan, South Korea

    Young Mi Seol

  15. Department of Internal Medicine, Gyeongsang National University School of Medicine, Jinju, South Korea

    Jung Hun Kang

  16. Department of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul, South Korea

    Young Jin Yuh

  17. Department of Internal Medicine, Seoul Medical Center, Seoul, South Korea

    So Yeon Oh

  18. Medical Affairs, Janssen Korea, Seoul, South Korea

    Suk Ran Kim

  19. Department of Medicine, Samsung Medical Center, Seoul, South Korea

    Jin Seok Ahn

  20. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong Gangnam-gu, Seoul, 135-710, South Korea

    Jin Seok Ahn

Authors
  1. Hye-Suk Han
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  2. Ki Hyeong Lee
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  5. Young Chul Kim
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  7. Ho-Suk Oh
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  8. Kyung Tae Park
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  9. Jung Hye Kwon
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  11. Won Sik Lee
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  12. Yang Soo Kim
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  13. Joong Bae Ahn
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  14. Seong Woo Jeon
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  15. Sung Yong Lee
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  16. Young Mi Seol
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  17. Jung Hun Kang
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  18. Young Jin Yuh
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  19. So Yeon Oh
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  20. Suk Ran Kim
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  21. Jin Seok Ahn
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Corresponding author

Correspondence to Jin Seok Ahn.

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Han, HS., Lee, K.H., Lee, K.H. et al. A prospective, open-label, multicenter study of the clinical efficacy of extended-release hydromorphone in treating cancer pain inadequately controlled by other analgesics. Support Care Cancer 22, 741–750 (2014). https://doi.org/10.1007/s00520-013-2030-1

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  • DOI: https://doi.org/10.1007/s00520-013-2030-1

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