An Effectiveness, Safety and Quality of Life Measures With Hydromorphone HCL, Dilaudid CR (Controlled Release)

April 26, 2010 updated by: Alza Corporation, DE, USA

A Randomized, Repeated- Dose, Parallel-Group Comparison of Safety, Efficacy, and Quality of Life Measures With Dilaudid CR (Hydromorphone HCI) or Oxycontin (Oxycodone HCI) in Patients With Chronic Osteoarthritis

The purpose of this study was to characterize the effectiveness and safety of OROS hydromorphone HCL and OxyContin in patients with chronic osteoarthritis (OA) of the knee or hip who are receiving chronic nonsteroidal anti-inflammatory drug (NSAID) or other nonsteroidal, non-opioid analgesic (ie, acetaminophen or aspirin) therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a multicenter, open-label, randomized (patients are assigned different treatments based on chance), dose-titration, parallel-group study characterizing the effectiveness and safety of OROS hydromorphone HCL and OxyContin in adult patients with osteoarthritis (OA) of the knee or hip who were unable to consistently control or treat their osteoarthritis pain with non opioid medications or with as-needed use of an opioid analgesic. The study consisted of a 14-day period for randomization, dose-titration, and stabilization, followed by a 4-week maintenance phase. Eligible patients were randomized equally to begin therapy with either OROS hydromorphone HCL 8 mg daily or OxyContin 10 mg twice daily. Upward dose titration (doses with increase in titration) from the starting doses was allowed every 2 days, based on pain relief and opioid-related side effects. The dose was to have been titrated to provide the best balance between pain relief and side effects. After 14 days, if therapeutic efficacy with dose stabilization had been documented, the patient was allowed to begin the 4-week maintenance phase. The expected primary efficacy variable endpoints were: The mean pain relief score at endpoint defined as the mean of the last 2 non missing pain relief scores during the Maintenance Phase, and the days from study medication initiation to the third day of moderate to complete pain relief on the patient's final titrated dose (as reported in the patient diary) during the Randomization, Titration and Stabilization Phase. Safety was evaluated by adverse events (AEs), vital signs, and physical examinations. OROS hydromorphone HCL 8mg tablet orally daily or OxyContin 10mg tablet orally daily; Upward dose titration from the starting doses was allowed every 2 days, based on pain relief and opioid-related side effects; After 14 days of efficacy with dose stabilization, patient was allowed to begin the 4 week maintenance phase.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

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:

  • Patient who met criteria (functional Class I-III in the hip or knee) for osteoarthritis for at least 3 months before enrollment
  • Patient who had moderate to severe chronic pain despite regular use and stable doses of an NSAID (nonsteroidal anti-inflammatory drug) or an NSAID with opioid analgesic taken as needed but not on a daily basis for the treatment of osteoarthritis.

Exclusion Criteria:

  • Patient intolerant of or hypersensitive to hydromorphone or oxycodone
  • Patient of childbearing potential must use medically recognized contraceptive program before and during the study
  • Pregnant or breastfeeding
  • Patient who had prior joint replacement of the target knee or hip
  • Patient with significant respiratory compromise or depressed ventilatory function
  • Patient who was known active drug abuser or alcoholics.

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Two primary efficacy:The mean pain relief score at endpoint during the Maintenance Phase. The day from study medication initiation to the third day of moderate to complete pain relief on the final titrated dose during all three phases.

Collaborators and Investigators

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

Sponsor

Alza Corporation, DE, USA

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 Completion (Actual)

May 1, 2001

Study Registration Dates

First Submitted

November 10, 2006

First Submitted That Met QC Criteria

November 10, 2006

First Posted (Estimate)

November 14, 2006

Study Record Updates

Last Update Posted (Estimate)

April 27, 2010

Last Update Submitted That Met QC Criteria

April 26, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR013270

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.

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