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).
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 on the incidence of side
effects associated with treatment with opioids during treatment where the 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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint was the control of pain during treatment. Pain was assessed by the visual analogue scale. Pain severity was assessed at each follow-up visit.
Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial
Spain: Spanish Drug Agency