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Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00365898
Recruitment Status : Terminated
First Posted : August 18, 2006
Last Update Posted : August 18, 2006
Information provided by:
Purdue Pharma LP

Brief Summary:
The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.

Condition or disease Intervention/treatment Phase
Chronic Non-Malignant Pain Drug: Hydromorphone Hydrochloride Extended-Release Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study of the Efficacy and Safety of 8 Mg Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
Study Start Date : July 2005
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  1. Patient Global Assessment of Pain Medication
  2. Pain Control Questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00365898

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United States, Arizona
Arizona Research Center 2525 W. Greenway Rd. Suite 114
Phoenix, Arizona, United States, 85023
United States, Florida
Clinical Research of West Florida, Inc. 2147 NE Coachman Road
Clearwater, Florida, United States, 33765
LCFP, Inc. 12631 World Plaza Lane Building 54
Ft. Myers, Florida, United States, 33907
Pharmaceutical Research Associates 1395 N. Courtenay Pkwy
Merritt Island, Florida, United States, 33161
Stedman Clinical Trials 3212 Cove Bend Drive
Tampa, Florida, United States, 33613
Palm Beach Research Center 1897 Palm Beach Lakes Blvd.
West Palm Beach, Florida, United States, 33409
Gold Coast Research 2965 Surrey Lane
Weston, Florida, United States, 33331
United States, North Carolina
PharmQuest 301 E Wendover Avenue Suite 411
Greensboro, North Carolina, United States, 27401
United States, Ohio
Hightop Medical Research Center 6103 Hamilton Anenue
Cincinnati, Ohio, United States, 45224
Research Institute of Greater Dayton 1010 Woodman Drive
Dayton, Ohio, United States, 45432
Pharmacotherapy Research Associates, Inc. 3620 Court Drive
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Allegheny Pain Management-PC 1402 Ninth Ave
Altoona, Pennsylvania, United States, 16602
he Tipton Medical & Diagnostic Center #334 Route 220
Tipton, Pennsylvania, United States, 16684
Preferred Primary Care Physicians 202 Jacob Murphy Lane
Uniontown, Pennsylvania, United States, 15401
Sponsors and Collaborators
Purdue Pharma LP
Layout table for additonal information Identifier: NCT00365898    
Other Study ID Numbers: HMP3011
First Posted: August 18, 2006    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006
Keywords provided by Purdue Pharma LP:
Chronic non-malignant pain, opioid
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents