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

Chronic Non-Malignant Pain Clinical Trial

Official title:

A Study of the Efficacy and Safety of 8 Mg Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00365898
• Other study ID #: HMP3011
• Status: Terminated
• Phase: Phase 3
• First received: August 16, 2006
• Last updated: August 16, 2006
• Start date: July 2005
• Est. completion date: July 2005

Study information

• Verified date: August 2006
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 380
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Non-Malignant Pain

Intervention

Drug:
• Hydromorphone Hydrochloride Extended-Release

Locations

Country	Name	City	State
United States	Allegheny Pain Management-PC 1402 Ninth Ave	Altoona	Pennsylvania
United States	Hightop Medical Research Center 6103 Hamilton Anenue	Cincinnati	Ohio
United States	Clinical Research of West Florida, Inc. 2147 NE Coachman Road	Clearwater	Florida
United States	Research Institute of Greater Dayton 1010 Woodman Drive	Dayton	Ohio
United States	LCFP, Inc. 12631 World Plaza Lane Building 54	Ft. Myers	Florida
United States	PharmQuest 301 E Wendover Avenue Suite 411	Greensboro	North Carolina
United States	Pharmaceutical Research Associates 1395 N. Courtenay Pkwy	Merritt Island	Florida
United States	Arizona Research Center 2525 W. Greenway Rd. Suite 114	Phoenix	Arizona
United States	Stedman Clinical Trials 3212 Cove Bend Drive	Tampa	Florida
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	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	Pharmacotherapy Research Associates, Inc. 3620 Court Drive	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Global Assessment of Pain Medication
Secondary	Pain Control Questionnaire