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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00410787
• Other study ID #: CR013264
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2006
• Last updated: April 26, 2010
• Est. completion date: April 2002

Study information

• Verified date: April 2010
• Source: Alza Corporation, DE, USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesics, Opioid
• Pain

Intervention

Drug:
• OROS hydromorphone HCI (slow release)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alza Corporation, DE, USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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