Status:
TERMINATED
Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
Lead Sponsor:
Purdue Pharma LP
Conditions:
Chronic Non-Malignant Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.
Detailed Description
The primary efficacy objective of this study is to compare the time to emergence of inadequate analgesia of 8 mg Hydromorphone Hydrochloride Extended-Release taken once every 24 hours versus placebo i...
Eligibility Criteria
Inclusion
- persistent, moderate-to-severe noncancer related pain requiring continuous analgesia for weeks to months, or longer, who are currently taking 20 to 40 mg of oxycodone or opioid equivalents per day for control of their persistent pain and who are willing to accept the possibility of receiving placebo during the Double-Blind Phase
Exclusion
- Patients already receiving opioid medication at an average total daily dose greater than 40 mg of oxycodone or opioid equivalents during the last week prior to study entry.
- Other protocol-specific exclusion/inclusion criteria may apply.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00365898
Start Date
July 1 2005
End Date
July 1 2005
Last Update
August 18 2006
Active Locations (14)
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1
Arizona Research Center 2525 W. Greenway Rd. Suite 114
Phoenix, Arizona, United States, 85023
2
Clinical Research of West Florida, Inc. 2147 NE Coachman Road
Clearwater, Florida, United States, 33765
3
LCFP, Inc. 12631 World Plaza Lane Building 54
Fort Myers, Florida, United States, 33907
4
Pharmaceutical Research Associates 1395 N. Courtenay Pkwy
Merritt Island, Florida, United States, 33161