Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
This study has been terminated.
Sponsor:
Purdue Pharma LP
Information provided by:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00365898
First received: August 16, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
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Purpose
The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Non-Malignant Pain |
Drug: Hydromorphone Hydrochloride Extended-Release |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by Purdue Pharma LP:
Primary Outcome Measures:
- 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:
- Patient Global Assessment of Pain Medication
- Pain Control Questionnaire
| Estimated Enrollment: | 380 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | July 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365898
Locations
| 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
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00365898 History of Changes |
| Other Study ID Numbers: | HMP3011 |
| Study First Received: | August 16, 2006 |
| Last Updated: | August 16, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Purdue Pharma LP:
|
Chronic non-malignant pain, opioid |
Additional relevant MeSH terms:
|
Hydromorphone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013