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

This study has been terminated.
Sponsor:
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
  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
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.

  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
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, see Learn About Clinical Studies.

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 July 29, 2014