Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain

Last updated: October 1, 2013
Sponsor: Janssen Pharmaceutica
Overall Status: Terminated

Phase

4

Condition

Pain

Chronic Pain

Cancer Pain

Treatment

N/A

Clinical Study ID

NCT01648699
CR016351
42801PAI4008
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant with histological confirmed malignancy

  • Participant on stable morphine or 25 milligram oxycodone dose equivalent per day.Stable dose is defined as no dose change for 3 consecutive days and does not requiremore than 3 doses of rescue medication per day

  • Life expectancy of at least 3 months

  • Negative urine pregnancy test

  • Participants with signed informed consent

Exclusion

Exclusion Criteria:

  • Participant intolerant or hypersensitive to hydromorphone or other opioid agonist

  • Participant with unstable medical condition

  • Participant with renal dysfunction and liver dysfunction

  • Participant dependence to opiates

  • Inability to take oral medication

Study Design

Total Participants: 20
Study Start date:
April 01, 2010
Estimated Completion Date:
September 30, 2010

Study Description

This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of OROS hydromorphone among participants with cancer pain. The duration of this study will be 28 days and will include visits at: Day 0 (Baseline), Day 7, 14 and 28. The OROS hydromorphone will be administered orally for 28 days and dose titration (incremental increase in drug dosage to a level that provides the optimal therapeutic effect) will be done every two days upon administration of dose. Rescue medication (a medication intended to relieve symptoms immediately) of morphine will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Brief Pain Inventory score. Participants' safety will be monitored throughout the study.

Connect with a study center

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    Cebuu City,
    Philippines

    Site Not Available

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    Davao City,
    Philippines

    Site Not Available

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    Manila,
    Philippines

    Site Not Available

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    Pasig National Capitol Region,
    Philippines

    Site Not Available

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    Quezon City,
    Philippines

    Site Not Available

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