An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Analgesics, Opioid; Hydromorphone; Oxycodone

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