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

NCT ID: NCT00410787

Last Updated: 2010-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2002-04-30

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

Conditions

Analgesics, Opioid; Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

OROS hydromorphone HCI (slow release)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alza Corporation, DE, USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Alza Corporation Clinical Trial

Role: STUDY_DIRECTOR

ALZA

Other Identifiers

CR013264

Identifier Type: -

Identifier Source: org_study_id