A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain

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

A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR (Hydromorphone HCI) in Patients With Chronic Non-Malignant Pain

The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain converting from other strong oral or transdermal opioids. It will also assist in the development of a recommended starting dose by which patients can be titrated to an appropriate maintenance dose of OROS Hydromorphone HCI. The safety profile for OROS Hydromorphone HCI will also be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This single-blind (with respect to dose), repeated dose study evaluating patients with chronic non-malignant pain was conducted in tandem with a similar protocol in patients with chronic cancer pain. A total of 463 patients were enrolled and evaluated in these studies. Patients receiving chronic opioid therapy were converted to once daily OROS hydromorphone using oral morphine equivalents. Supplementary immediate-release (IR) hydromorphone was provided for breakthrough pain. The dose of OROS hydromorphone was escalated after every 2 days of therapy until no more than 3 doses of immediate-release(IR) hydromorphone were required in a 24-hour period. Once a patient could be maintained on a stable dose of OROS hydromorphone for 3 consecutive days, the patient entered a 2-week maintenance phase. Patients who completed the study were eligible for participation in an OROS hydromorphone long-term extension study, Study DO-109. The hypothesis is the 24-hour controlled-release form of oral hydromorphone may provide consistent pain relief, convenient dosing, and enhanced compliance while possibly decreasing the incidence of side effects associated with peak (high) and trough (low) fluctuations in plasma drug concentrations typically seen with immediate-release dosage formulations. Patients received OROS Hydromorphone HCI at Visit 2,3, and 4(either 8,16,32, and/or 64mg tablets) taken orally. OROS Hydromorphone HCI doses were titrated after every two days of therapy as necessary until dose stabilization occurred, followed by a two week Maintenance Therapy Phase.

Study Type

Interventional

Enrollment (Actual)

463

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have chronic non-malignant pain, including pain associated with AIDS, who are currently receiving strong oral or transdermal opioid analgesics, or patients who are currently receiving opioids plus non-opioid combination analgesics, and have persisting pain
  • patients who require at least 45 mg of oral morphine or opioid equivalent every 24 hours for the management of chronic non-malignant pain
  • patients who can reasonably be expected to have stable opioid requirements for the duration of the study.

Exclusion Criteria:

  • Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
  • patients who have dysphagia or are unable to swallow tablets
  • patients who are pregnant or breast-feeding
  • patients with severe respiratory compromise or severely depressed ventilatory function
  • patients with any gastrointestinal disorder, including pre-existing severe GI narrowing(pathologic or iatrogenic), that may affect the absorption or transit of orally administered drugs or have an acute abdominal condition that may be obscured by opioids
  • patients with clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
  • patients who are known active drug abusers or alcoholics
  • patients with any significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
No primary efficacy variable was defined in report. Protocol variables measured included: Total daily dose of OROS hydromorphone, daily use of rescue medication, daily pain relief scores, and time/number of steps needed for dose stabilization.

Collaborators and Investigators

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

Sponsor

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.

General Publications

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)

February 1, 1999

Study Registration Dates

First Submitted

December 12, 2006

First Submitted That Met QC Criteria

December 12, 2006

First Posted (Estimate)

December 13, 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

  • CR011617

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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