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

NCT00410787 | Completed Phase 3

• 1 other identifier: CR013264
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Analgesics, Opioid; Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

OROS hydromorphone HCI (slow release) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alza Corporation Clinical Trial

  ALZA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 13, 2006
• Study Completion: April 1, 2002
• Last Updated: April 27, 2010

Record last verified: 2010-04