An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain
Condition: Pain
Intervention: Hydromorphone HCl; Oxycodone HCl CR; Placebo
Intervention description: Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of Titration phase and 28 days of Maintenance phase. Starting dose will be based on participant's previous daily opioid dose.; Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose.; Placebo will be administered to the participants receiving hydromorphone HCl or oxycodone HCl CR along with the study treatment to maintain necessary blinding.
Intervention MeSH terms: Oxycodone; Hydromorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Pain; Hydromorphone hydrochloride; Oxycodone hydrochloride

Summary:

      The purpose of this study is to compare the safety and efficacy of Oral Osmotic Therapeutic
      System (OROS) hydromorphone hydrochloride (HCl) with controlled-release oxycodone HCl in
      participants with cancer-related pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants receiving strong oral or transdermal (through the skin) opioid analgesics
             with inadequate control of moderate to severe (very serious, life threatening) cancer
             pain or who presented with cancer pain and will be eligible to move to Step 3 of the
             WHO analgesic ladder when receiving weak opioids

          -  Participants who require or are expected to require between 40 mg and 184 mg of oral
             morphine or morphine equivalents every 24 hours for the chronic management of cancer
             pain

          -  Participants who are reasonably expected to achieve a stable dose of opioid study
             medication during the study

          -  Participants who are not expected to start a course of chemotherapy, radiotherapy,
             targeted cancer therapy, hormone therapy or diphosphates therapy after enrolment into
             the study. If participants are receiving long-term treatment including hormone
             therapy, target cancer therapy and diphosphate, the treatment should be kept stable as
             much as possible from 2 weeks before randomization and up to the completion of the
             study, encompassing the titration and maintenance phases

          -  Female participants who are premenarchal, postmenopausal, or surgically sterile,
             abstinent or if sexually active, they must use a medically acceptable method of
             contraception and must be willing to continue to use the same method of contraception
             throughout the study

        Exclusion Criteria:

          -  Participants with neuropathic pain or pain of unknown origin, or acute pain -
             Participants having pain only on movements

          -  Participants requiring other opioid analgesics (apart from morphine hydrochloride
             (HCl), in immediate release formulation, allowed as rescue medication for breakthrough
             pain)

          -  Participants with a recent history (within the previous 6 months) or current history
             of drug abuse or alcohol abuse

          -  Women of childbearing potential who were pregnant or lactating, seeking pregnancy or
             failing to use an adequate contraceptive method