MedDataX Logo

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

NCT ID: NCT00365898

Last Updated: 2006-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Non-Malignant Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Chronic non-malignant pain, opioid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hydromorphone Hydrochloride Extended-Release

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Purdue Pharma LP

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arizona Research Center 2525 W. Greenway Rd. Suite 114

Phoenix, Arizona, United States

Site Status

Clinical Research of West Florida, Inc. 2147 NE Coachman Road

Clearwater, Florida, United States

Site Status

LCFP, Inc. 12631 World Plaza Lane Building 54

Fort Myers, Florida, United States

Site Status

Pharmaceutical Research Associates 1395 N. Courtenay Pkwy

Merritt Island, Florida, United States

Site Status

Stedman Clinical Trials 3212 Cove Bend Drive

Tampa, Florida, United States

Site Status

Palm Beach Research Center 1897 Palm Beach Lakes Blvd.

West Palm Beach, Florida, United States

Site Status

Gold Coast Research 2965 Surrey Lane

Weston, Florida, United States

Site Status

PharmQuest 301 E Wendover Avenue Suite 411

Greensboro, North Carolina, United States

Site Status

Hightop Medical Research Center 6103 Hamilton Anenue

Cincinnati, Ohio, United States

Site Status

Research Institute of Greater Dayton 1010 Woodman Drive

Dayton, Ohio, United States

Site Status

Pharmacotherapy Research Associates, Inc. 3620 Court Drive

Zanesville, Ohio, United States

Site Status

Allegheny Pain Management-PC 1402 Ninth Ave

Altoona, Pennsylvania, United States

Site Status

he Tipton Medical & Diagnostic Center #334 Route 220

Tipton, Pennsylvania, United States

Site Status

Preferred Primary Care Physicians 202 Jacob Murphy Lane

Uniontown, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HMP3011

Identifier Type: -

Identifier Source: org_study_id