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

August 16, 2006 updated by: Purdue Pharma LP

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

380

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center 2525 W. Greenway Rd. Suite 114
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc. 2147 NE Coachman Road
      • Ft. Myers, Florida, United States, 33907
        • LCFP, Inc. 12631 World Plaza Lane Building 54
      • Merritt Island, Florida, United States, 33161
        • Pharmaceutical Research Associates 1395 N. Courtenay Pkwy
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials 3212 Cove Bend Drive
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center 1897 Palm Beach Lakes Blvd.
      • Weston, Florida, United States, 33331
        • Gold Coast Research 2965 Surrey Lane
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • PharmQuest 301 E Wendover Avenue Suite 411
    • Ohio
      • Cincinnati, Ohio, United States, 45224
        • Hightop Medical Research Center 6103 Hamilton Anenue
      • Dayton, Ohio, United States, 45432
        • Research Institute of Greater Dayton 1010 Woodman Drive
      • Zanesville, Ohio, United States, 43701
        • Pharmacotherapy Research Associates, Inc. 3620 Court Drive
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Allegheny Pain Management-PC 1402 Ninth Ave
      • Tipton, Pennsylvania, United States, 16684
        • he Tipton Medical & Diagnostic Center #334 Route 220
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians 202 Jacob Murphy Lane

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Patient Global Assessment of Pain Medication
Pain Control Questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue Pharma LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

August 16, 2006

First Submitted That Met QC Criteria

August 16, 2006

First Posted (Estimate)

August 18, 2006

Study Record Updates

Last Update Posted (Estimate)

August 18, 2006

Last Update Submitted That Met QC Criteria

August 16, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMP3011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Non-Malignant Pain

Clinical Trials on Hydromorphone Hydrochloride Extended-Release

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe