Safety and Tolerability of Long-term Administration of OROS Hydromorphone HCI (Slow Release) in Cancer Pain

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

Safety and Tolerability of Long-Term Administration of Dilaudid SR (Hydromorphone HCI) in Cancer Pain

The primary purpose of this study was to characterize the pain control achieved with long-term repeated dosing of OROS hydromorphone (slow release) in patients with chronic cancer pain and the secondary purpose was to characterize the effects of pain on the patients' quality of life with long-term, repeated dosing of OROS hydromorphone (slow release) taken by patients with chronic cancer pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study DO-118X was a phase-3, multicenter, open-label extension study in adult patients with cancer pain who had successfully completed Study DO-118 with dose-stable pain control taking at least 8 mg of OROS hydromorphone (slow release) or its equivalent morphine sulfate SR (slow release) dosage. Patients were started on the dose of OROS hydromorphone equivalent to the opioid dose on which they had achieved dose-stable pain control in the SR (slow release) phase of Study DO-118. Patients returned to their study clinic once a month for 1 year. Dosage adjustments to study medications and breakthrough pain medication were permitted. OROS hydromorphone HCI (slow release) tablets in 8, 16, 32 and 64mg doses administered orally every 24 hours

Study Type

Interventional

Enrollment (Actual)

68

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 cancer pain, and who have successfully completed the OROS hydromorphone SR (slow release) study, DO-118
  • Patients must have been in dose-stable pain control in the last two days of the slow release phase of the study
  • Patients who require at least 8mg of OROS hydromorphone slow release every 24 hours for the management of chronic cancer pain

Exclusion Criteria:

  • Pain which is not considered to be potentially responsive to opioids
  • Gastrointestinal disease of sufficient severity to be likely to interfere with oral analgesia including: dysphagia, vomiting, no bowel movement or bowel obstruction due to impaction within the 5 days prior to the start of the trial, severe gut narrowing that may affect the absorption or transit of orally administered drugs, particularly the insoluble OROS outer coating
  • Any patient in whom the risks of treatment with hydromorphone outweigh the potential benefits. Such risk categories include: raised intracranial pressure, hypotension, hypothyroidism, asthma, reduced respiratory reserve, prostatic hypertrophy, hepatic impairment, renal impairment, elderly and debilitated, convulsive disorders and Addison's disease

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Study results indicated that long-term treatment with OROS hydromorphone can be useful in the management of persistent, moderate-to-severe chronic pain in patients with cancer

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)

April 1, 2002

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

  • CR013264

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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