Status:
TERMINATED
A Study to Compare Safety and Efficacy of Osmotic Release Oral Syytem (OROS) Hydromorphone Hydrochloride (HCl) With Morphine Sustain Release (SR) in Participants With Cancer Pain
Lead Sponsor:
Johnson & Johnson Taiwan Ltd
Conditions:
Cancer Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorohone Hydrochloride (HCl) compared with morphine sustain release (SR) in participant...
Detailed Description
This is an open-label (all people know the identity of the intervention), multi-center (when more than 1 hospital or medical school team work on a medical research study), active-controlled, randomize...
Eligibility Criteria
Inclusion
- Participants with cancer pain and experiencing inadequate pain control on or approaching Step 2 of the World Health Organisation (WHO) analgesic ladder
- Participants with pain scores greater than and equal to 4 on the average in the last 24 hours
- Participants requiring or are expected to require not more than 540 milligram of oral morphine or morphine equivalent every 24 hours for the management of chronic cancer pain
- Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial
- Participants who can reasonably be expected to achieve stable dose of opioid study medication for the duration of the trial
Exclusion
- Participants with pure or predominantly neuropathic pain or pain of unknown origin (where a mechanism or physical cause cannot be identified)
- Participants with acute pain or who have pain on movement
- Participants who have received a fentanyl patch within the last 5 days
- Participants intolerant or hypersensitive to hydromorphone or other opioids agonists (chemical substance capable of activating a receptor to induce a full or partial response)
- Participants with recent past history (within the previous 5 years) or current history of drug abuse or alcohol abuse
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00803283
Start Date
November 1 2008
End Date
December 1 2008
Last Update
August 12 2013
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