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

Primary Purpose

Analgesics, Opioid, Pain

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

OROS hydromorphone HCI (slow release)

About this trial

This is an interventional treatment trial for Analgesics, Opioid focused on measuring Chronic cancer pain, OROS hydromorphone HCI (slow release), long-term repeated dosing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00410787

First Posted

December 12, 2006

Last Updated

April 26, 2010

Sponsor

Alza Corporation, DE, USA

1. Study Identification

Unique Protocol Identification Number

NCT00410787

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

April 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Alza Corporation, DE, USA

4. Oversight

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Analgesics, Opioid, Pain

Keywords

Chronic cancer pain, OROS hydromorphone HCI (slow release), long-term repeated dosing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

OROS hydromorphone HCI (slow release)

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alza Corporation Clinical Trial

Organizational Affiliation

ALZA

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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