A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis

July 4, 2013 updated by: Alza Corporation, DE, USA

A Phase 3, Randomized, Double-Blind, Fixed-Dose, Parallel Group Comparison of Controlled-Release Hydromorphone HCI vs Placebo in Subjects With Osteoarthritis

The purpose of this study was to compare the analgesic (a drug that relieves pain) effectiveness and safety of OROS hydromorphone HCI (slow release) 8 mg and 16 mg to placebo (no drug) in patients with osteoarthritis (OA).

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 phase 3, randomized (patients are assigned different treatments based on chance), placebo-controlled, double-blind, fixed-dose, parallel-group, multicenter study in adult patients with OA (osteoarthritis) who were unable to consistently control or treat their pain with nonopioid medications, or who had received an opioid for treatment of pain. Eligible patients were randomized in an equal ratio to receive 1 of 3 treatments: OROS hydromorphone HCI (slow release) 8mg, OROS hydromorphone HCI (slow release) 16 mg, or placebo (no drug). All patients could take acetaminophen (less than or equal to 2000 mg per day) as rescue medication for osteoarthritic pain. Rescue medication was not permitted during the washout period or 6 hours before an assessment of effectiveness. The study was comprised of the following periods: an analgesic (pain reliever) taper and washout period (less than or equal to 2 weeks), a Titration (increase)Phase (less than or equal to 16 days), a Maintenance Phase (12 weeks), and a study drug taper period (less than or equal to 1 week). At the end of the washout period, all patients received OROS hydromorphone HCI (slow release) 8 mg or matching placebo to be taken once daily. After 1 week, patients were to return to the study site and receive new supplies of study drug. During the second week of titration (increase), patients randomized to the OROS hydromorphone (slow release) 16 mg group had their dose increased from 8 mg daily to 16 mg daily of OROS hydromorphone (slow release). No dose adjustments were allowed. After completing the Maintenance Phase or upon early termination, study drug was tapered for up to 1 week as follows: one 8 mg tablet or placebo once daily for the first 2 days then taken every other day as appropriate to taper off the study medication. Safety assessments of physical examination, vital signs, labs and adverse event reporting were done at baseline, termination throughout the study. The primary measurement was the time-interval weighted area under the curve(AUC) divided by the maximum AUC benefit possible for an individual. The AUC was a measure of cumulative pain intensity differences from baseline for the Titration and Maintenance phases. At termination, patients were assigned their baseline pain value for the remainder of the trial, baseline observation carried forward (BOCF) or the last available pain value for the remainder of the trial, last observation carried forward (LOCF). Western Ontario and McMaster Osteoarthritis Index (WOMAC) overall index score, physical function, joint stiffness subscales were analyzed using the AUC ratio and change from baseline using no imputation, and the baseline observation carried forward (BOCF) and last observation carried forward (LOCF) imputation methods. The medical outcome study (MOS) sleep scale was also analyzed per protocol. OROS hydromorphone (slow release) 8 mg and 16 mg tablets and placebo taken orally once daily for 17 weeks

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.
990

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must have a negative pregnancy test at screening and be postmenopausal for at least 1 year or surgically sterile or practicing a medically recognized contraceptive program
  • Patient has been diagnosed with Functional Class I-III Osteoarthritis of the knee or hip
  • Patient has required treatment of target joint pain within the 90 days prior to study start and met at least one of the following: was unable to consistently control target joint pain with non-opioid pain reliever, unable to treat target joint pain with non-opioid pain reliever because treatment was contraindicated per investigator judgement, or had received an opioid(single or combination product) for treatment of target joint pain, with the equivalent of less than or equal to 40 mg/day of oral morphine sulfate, inclusive of breakthrough pain medication
  • Patient has reported a target joint pain score of at least 5 (11-point Likert Scale) at baseline

Exclusion Criteria:

  • Patient for whom hydromorphone was contraindicated because of a documented history of an allergic reaction (hives, rash, etc) or a clinically significant intolerance to hydromorphone or other opioids
  • Patient requiring treatment with monoamine oxidase inhibitors, or receiving systemic chemotherapy or had an active malignancy of any type or had clinically significant abnormalities in clinical chemistry, hematology or urinalysis, or had a documented history of gout, pseudogout, Paget's disease, fibromyalgia
  • uncontrolled inflammatory arthritis or NSAID-dependent inflammatory arthritis or any chronic pain syndrome that could interfere with the assessment of pain and/or other symptoms of osteoarthritis
  • Patient who is pregnant and/or breastfeeding
  • Patient with a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse, or unable to discontinue all formulations of prior pain medications (opioid and/or non-opioid) during the washout period of the study
  • Patient who had a documented history of a medical condition, which, in the investigator's opinion, could compromise the patient's ability to swallow, absorb, metabolize, or excrete study drug, including (but not limited to) intractable nausea and/or vomiting, and/or severe gastrointestinal narrowing

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

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
Time-interval weighted AUC pain ratio (AUC/by an individual's maximum possible benefit AUC)using Baseline Observation Carried Forward imputation(up to Week 12); AUC was the cumulative pain intensity differences from baseline (titration and maintenance).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
WOMAC pain subscale for the AUC ratio and change from baseline at each time point; Index score and other subscale analyzed using the AUC ratio and change from baseline (no imputation, BOCF and LOCF imputation); Other included MOS Sleep Scale.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2003

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, 2005

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).
December 12, 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.
December 12, 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.
December 13, 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.
July 8, 2013

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.
July 4, 2013

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.
July 1, 2013

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.
  • CR013273

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