A STUDY TO TEST THE FEASIBILITY OF A TWO-ARM, TRIAL FOR THE COMPARISON OF THE DURATION OF THE ANALGESIC EFFICACY OF A SINGLE MATRIX TRANSDERMAL FENTANYL PATCH COMPARED VS A DOUBLE MATRIX TRANSDERMAL FENTANYL PATCH .
- Conditions
- Patients with oncological painMedDRA version: 20.0Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditionsTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-000944-41-IT
- Lead Sponsor
- FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
•Pain due to active oncological disease
•Age = 18 years
•Pain treatment with stable dosage of Durogesic® in the previous six days, in need of substituting the patch at or before 60 hours of treatment.
•Pain controlled (average pain intensity in the previous 24 hours = 4/10)
• rescue medications for the treatment of breakthrough pain for a maximum of three daily KPS = 50
•Written informed consent to study participation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
•Patients using 12,5 mcg/h patch size
•Radiation therapy and/or chemotherapy within 15 days prior to enrollment
•Cognitive deficits compromising the ability to assess pain or pain relief
•Pregnancy or breastfeeding
•Severe hepatic and/or renal impairment
•Participation in other clinical trials that might interfere with the study results
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method