- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00365898
Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
August 16, 2006 updated by: Purdue Pharma LP
A Study of the Efficacy and Safety of 8 Mg Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
380
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85023
- Arizona Research Center 2525 W. Greenway Rd. Suite 114
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Florida
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Clearwater, Florida, United States, 33765
- Clinical Research of West Florida, Inc. 2147 NE Coachman Road
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Ft. Myers, Florida, United States, 33907
- LCFP, Inc. 12631 World Plaza Lane Building 54
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Merritt Island, Florida, United States, 33161
- Pharmaceutical Research Associates 1395 N. Courtenay Pkwy
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Tampa, Florida, United States, 33613
- Stedman Clinical Trials 3212 Cove Bend Drive
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West Palm Beach, Florida, United States, 33409
- Palm Beach Research Center 1897 Palm Beach Lakes Blvd.
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Weston, Florida, United States, 33331
- Gold Coast Research 2965 Surrey Lane
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North Carolina
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Greensboro, North Carolina, United States, 27401
- PharmQuest 301 E Wendover Avenue Suite 411
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Ohio
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Cincinnati, Ohio, United States, 45224
- Hightop Medical Research Center 6103 Hamilton Anenue
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Dayton, Ohio, United States, 45432
- Research Institute of Greater Dayton 1010 Woodman Drive
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Zanesville, Ohio, United States, 43701
- Pharmacotherapy Research Associates, Inc. 3620 Court Drive
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Pennsylvania
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Altoona, Pennsylvania, United States, 16602
- Allegheny Pain Management-PC 1402 Ninth Ave
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Tipton, Pennsylvania, United States, 16684
- he Tipton Medical & Diagnostic Center #334 Route 220
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Uniontown, Pennsylvania, United States, 15401
- Preferred Primary Care Physicians 202 Jacob Murphy Lane
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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Patient Global Assessment of Pain Medication
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Pain Control Questionnaire
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion
July 1, 2005
Study Registration Dates
First Submitted
August 16, 2006
First Submitted That Met QC Criteria
August 16, 2006
First Posted (Estimate)
August 18, 2006
Study Record Updates
Last Update Posted (Estimate)
August 18, 2006
Last Update Submitted That Met QC Criteria
August 16, 2006
Last Verified
August 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMP3011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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