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

Information source: Purdue Pharma LP
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Non-Malignant Pain

Intervention: Hydromorphone Hydrochloride Extended-Release (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Purdue Pharma LP

Summary

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

Clinical Details

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: 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:

Patient Global Assessment of Pain Medication

Pain Control Questionnaire

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Arizona Research Center 2525 W. Greenway Rd. Suite 114, Phoenix, Arizona 85023, United States

Gold Coast Research 2965 Surrey Lane, Weston, Florida 33331, United States

Palm Beach Research Center 1897 Palm Beach Lakes Blvd., West Palm Beach, Florida 33409, United States

LCFP, Inc. 12631 World Plaza Lane Building 54, Ft. Myers, Florida 33907, United States

Clinical Research of West Florida, Inc. 2147 NE Coachman Road, Clearwater, Florida 33765, United States

Stedman Clinical Trials 3212 Cove Bend Drive, Tampa, Florida 33613, United States

Pharmaceutical Research Associates 1395 N. Courtenay Pkwy, Merritt Island, Florida 33161, United States

PharmQuest 301 E Wendover Avenue Suite 411, Greensboro, North Carolina 27401, United States

Pharmacotherapy Research Associates, Inc. 3620 Court Drive, Zanesville, Ohio 43701, 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

Allegheny Pain Management-PC 1402 Ninth Ave, Altoona, Pennsylvania 16602, United States

Preferred Primary Care Physicians 202 Jacob Murphy Lane, Uniontown, Pennsylvania 15401, United States

he Tipton Medical & Diagnostic Center #334 Route 220, Tipton, Pennsylvania 16684, United States

Additional Information

Starting date: July 2005
Ending date: July 2005
Last updated: August 16, 2006

Page last updated: June 20, 2008

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