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Sponsored by: |
Janssen-Cilag S.A., (formerly Janssen Sp) |
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Information provided by: | Janssen-Cilag S.A., (formerly Janssen Sp) |
ClinicalTrials.gov Identifier: | NCT00576017 |
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.
Condition | Intervention | Phase |
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Pain |
Drug: Fentanyl-TTS |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
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). |
Estimated Enrollment: | 112 |
Study Start Date: | October 2003 |
Study Completion Date: | March 2005 |
This study is a multicenter, randomized(study drug assigned by chance), open-label, nationwide study. Patients with moderate to severe chronic pain due to the oncological disease (VAS>5) meeting the inclusion and exclusion criteria were randomized to treatment with fentanyl-TTS (transdermal patches, initial dosage: 25µg/h patch every 3 days, experimental drug) or with minor opioids (Tramadol, initial dosage of 200mg/day and Dihydrocodeine initial dosage of 120mg/day, control arm). The follow-up and drug administration was two months, during which controls were performed every 7 days, except for the first that was on Day 4. If pain was not controlled (VAS<3), the investigator could increase the dose of the relevant drug (according to data sheet). The primary endpoint has been the control of pain during treatment. Pain was assessed by the visual analogue scale. Pain severity was assessed at each follow-up visit. The secondary endpoint was to assess the advantages of using fentanyl-TTS after the first step of the WHO analgesic ladder as compared to minor opioids. These advantages were assessed based onthe incidence of side effects associated with treatment with opioids during treatment wherethe following was assessed by a table with the most common side effects: nausea, vomiting, constipation and drowsiness (WHO) and their severity, the quantity of support drugs required by the patients to cope with the side effects occurring, adverse events related to the study drug, and the percentage of patients discontinuing or switching treatment due to side effects.
Fentanyl, dosage forms: 25µg/h, 50µg/h and 100µg/h. Transdermal patches (initial dosage: 25µg/h patch every 3 days). Tramadol, dosage forms: 100mg, 150mg and 200mg, (initial dosage: 200mg/day). Dihydrocodeine, dosage forms: 60mg, 90mg and 120mg, (initial dosage: 120mg/day). If pain was not controlled (VAS<3), the investigator could increase the dose of the relevant drug. The follow-up and drug administration was two months, during which controls were performed every 7 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR003526 |
Study First Received: | December 14, 2007 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00576017 |
Health Authority: | Spain: Spanish Drug Agency |
Cancer pain Tramadol Fentanyl TTS Cancer pain treatment |
Dihydrocodeine Ultram Durogesic |
Fentanyl Dihydrocodeine Tramadol Asthenia Pain |
Anesthetics, Intravenous Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |