Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
A Study of the Efficacy and Safety of 8 Mg Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
1 other identifier
interventional
380
1 country
14
Brief Summary
The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2005
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 16, 2006
CompletedFirst Posted
Study publicly available on registry
August 18, 2006
CompletedAugust 18, 2006
August 1, 2006
August 16, 2006
August 16, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Patient Global Assessment of Pain Medication
Pain Control Questionnaire
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Purdue Pharma LPlead
Study Sites (14)
Arizona Research Center 2525 W. Greenway Rd. Suite 114
Phoenix, Arizona, 85023, United States
Clinical Research of West Florida, Inc. 2147 NE Coachman Road
Clearwater, Florida, 33765, United States
LCFP, Inc. 12631 World Plaza Lane Building 54
Fort Myers, Florida, 33907, United States
Pharmaceutical Research Associates 1395 N. Courtenay Pkwy
Merritt Island, Florida, 33161, United States
Stedman Clinical Trials 3212 Cove Bend Drive
Tampa, Florida, 33613, United States
Palm Beach Research Center 1897 Palm Beach Lakes Blvd.
West Palm Beach, Florida, 33409, United States
Gold Coast Research 2965 Surrey Lane
Weston, Florida, 33331, United States
PharmQuest 301 E Wendover Avenue Suite 411
Greensboro, North Carolina, 27401, United States
Hightop Medical Research Center 6103 Hamilton Anenue
Cincinnati, Ohio, 45224, United States
Research Institute of Greater Dayton 1010 Woodman Drive
Dayton, Ohio, 45432, United States
Pharmacotherapy Research Associates, Inc. 3620 Court Drive
Zanesville, Ohio, 43701, United States
Allegheny Pain Management-PC 1402 Ninth Ave
Altoona, Pennsylvania, 16602, United States
he Tipton Medical & Diagnostic Center #334 Route 220
Tipton, Pennsylvania, 16684, United States
Preferred Primary Care Physicians 202 Jacob Murphy Lane
Uniontown, Pennsylvania, 15401, United States
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 16, 2006
First Posted
August 18, 2006
Study Start
July 1, 2005
Study Completion
July 1, 2005
Last Updated
August 18, 2006
Record last verified: 2006-08