A Study to Evaluate the Safety and Effectiveness of Fentanyl-TTS Compared to Weak Opioids in Patients With Moderate to Severe Chronic Cancer Pain Previously Treated With NSAIDS (Non-steroidal Anti-inflammatory Drugs).

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To show, using the analgesic WHO scale, that fentanyl-TTS may be directly used for treating moderate to severe cancer pain in patients treated with NSAIDs, acetaminophen, or metamizole (first step drugs) avoiding the second step, and may be at least as effective and safe as currently used second step drugs, minor opioids.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag, S.A.
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Fentanyl

Criteria

Inclusion Criteria:

• Patients with moderate to severe chronic pain due to the oncological condition, defined as VAS => 5, treated with first step drugs, either NSAIDs or acetaminophen or metamizole (the dose of first step drugs requiring a switch in treatment is left to the physician's discretion)

• Patients with a documented histological diagnosis of cancer.

Exclusion Criteria:

• Patients whose pain has some neuropathic component

• Patients who have been treated with opioids during the 2 months prior to study entry

• Patients with dermatological disease, a history of allergy or hypersensitivity to fentanyl or to adhesive components preventing use of patches

• Patients with a history of cardiac, CNS, or respiratory disease that prevents their participation in the study in the investigator's judgment

• Patients with kidney or liver failure contraindicating use of opioids based on medical criterion

• Pregnant women or women of childbearing age who do not use an effective contraceptive method throughout the study

• Patients in whom surgery is planned during the study

• Patients who are participating at the same time in another trial.