NCT00959400

Efficacy and Safety Study of Fentanyl Transdermal (Fentanest®)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Eligible patients who agree to participate will migrate from oral opioids to transdermal patches and be followed for four weeks. Oral morphine will be provided as pain rescue medication. The patients will inform the adverse events and rescue medication consumption. The number of Fentanest® patches will be adjusted every visit aiming to reduce the rescue medication consumption and adverse events to a minimum. The WHO-QOL- bref (quality of life questionary) will be filled before and after the use of Fentanest®. Patients showing benefit are eligible to a 3 weeks compassionate study.

Conditions

• Pain
• Palliative Care

Interventions

Type	Name	Description
DRUG	Fentanyl Transdermal	Fentanest® 25 mcg/h. Each patch delivers 25 mcg of fentanyl per hour continuously for 72 hours. Therefore paches must be changed every 3 days.

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-06-01
• First posted: 2009-08-14
• Last updated: 2015-07-16

Locations

5 sites across 1 country: Brazil