Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
- Conditions
- Chronic Non-Malignant Pain
- Registration Number
- NCT00365898
- Lead Sponsor
- Purdue Pharma LP
- 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 in the treatment of patients with persistent pain who require an opioid medication for control of their pain.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 380
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to emergence of inadequate analgesia. Emergence of inadequate analgesia is defined as one or more of the following: a) the subject has a rating of poor or fair on the Patient Global Assessment of Pain Medicatio
- Secondary Outcome Measures
Name Time Method Pain Control Questionnaire Patient Global Assessment of Pain Medication
Trial Locations
- Locations (14)
Arizona Research Center 2525 W. Greenway Rd. Suite 114
🇺🇸Phoenix, Arizona, United States
Clinical Research of West Florida, Inc. 2147 NE Coachman Road
🇺🇸Clearwater, Florida, United States
LCFP, Inc. 12631 World Plaza Lane Building 54
🇺🇸Ft. Myers, Florida, United States
Pharmaceutical Research Associates 1395 N. Courtenay Pkwy
🇺🇸Merritt Island, Florida, United States
Stedman Clinical Trials 3212 Cove Bend Drive
🇺🇸Tampa, Florida, United States
Palm Beach Research Center 1897 Palm Beach Lakes Blvd.
🇺🇸West Palm Beach, Florida, United States
Gold Coast Research 2965 Surrey Lane
🇺🇸Weston, Florida, United States
PharmQuest 301 E Wendover Avenue Suite 411
🇺🇸Greensboro, North Carolina, United States
Hightop Medical Research Center 6103 Hamilton Anenue
🇺🇸Cincinnati, Ohio, United States
Research Institute of Greater Dayton 1010 Woodman Drive
🇺🇸Dayton, Ohio, United States
Scroll for more (4 remaining)Arizona Research Center 2525 W. Greenway Rd. Suite 114🇺🇸Phoenix, Arizona, United States