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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2001

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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