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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).

CompletedPhase 4NCT00576017
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Randomised Study to Evaluate the Efficacy and Safety of Fentanyl-TTS Versus Weak Opioids in Patients With Moderate to Severe Chronic Cancer Pain Previously Treated With NSAIDs (Non-steroidal Anti-inflammatory Drugs).
Conditions
Interventions
  • Drug: Fentanyl-TTS
Sponsor
Janssen-Cilag, S.A.
Start date
2003-10
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00576017