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

Stopped early · Phase 3

Conditions studied: Chronic Non-Malignant Pain

In brief

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

Key facts

Study ID

NCT00365898

Run by

Purdue Pharma LP

People needed

380

Starts

2005-07-01

Expected to finish

2005-07-01

Last updated by the study team

2006-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Arizona Research Center 2525 W. Greenway Rd. Suite 114 — Phoenix, Arizona, United States
• Clinical Research of West Florida, Inc. 2147 NE Coachman Road — Clearwater, Florida, United States
• LCFP, Inc. 12631 World Plaza Lane Building 54 — Fort Myers, Florida, United States
• Pharmaceutical Research Associates 1395 N. Courtenay Pkwy — Merritt Island, Florida, United States
• Stedman Clinical Trials 3212 Cove Bend Drive — Tampa, Florida, United States
• Palm Beach Research Center 1897 Palm Beach Lakes Blvd. — West Palm Beach, Florida, United States
• Gold Coast Research 2965 Surrey Lane — Weston, Florida, United States
• PharmQuest 301 E Wendover Avenue Suite 411 — Greensboro, North Carolina, United States
• Hightop Medical Research Center 6103 Hamilton Anenue — Cincinnati, Ohio, United States
• Research Institute of Greater Dayton 1010 Woodman Drive — Dayton, Ohio, United States
• Pharmacotherapy Research Associates, Inc. 3620 Court Drive — Zanesville, Ohio, United States
• Allegheny Pain Management-PC 1402 Ninth Ave — Altoona, Pennsylvania, United States
• he Tipton Medical & Diagnostic Center #334 Route 220 — Tipton, Pennsylvania, United States
• Preferred Primary Care Physicians 202 Jacob Murphy Lane — Uniontown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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