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).

This study has been completed.
Sponsor:
Information provided by:
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT00576017
First received: December 14, 2007
Last updated: May 18, 2011
Last verified: April 2010
  Purpose

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
Pain
Drug: Fentanyl-TTS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag, S.A.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 19
Study Start Date: October 2003
Study Completion Date: March 2005
Detailed Description:

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 7 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576017

Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00576017     History of Changes
Other Study ID Numbers: CR003526
Study First Received: December 14, 2007
Last Updated: May 18, 2011
Health Authority: Spain: Spanish Drug Agency

Keywords provided by Janssen-Cilag, S.A.:
Cancer pain treatment
Fentanyl TTS
Dihydrocodeine
Tramadol
Cancer pain
Durogesic
Ultram

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Antirheumatic Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014