Evaluation of efficacy and safety of analgesia with transmucosal fentanyl citrate in oncologic patients eligible to permanent central venous catheter

• Conditions: Cancer patients eligible to permanent central venous catheter due to chemotherapeutic treatment; MedDRA version: 15.0Level: PTClassification code 10053377Term: Central venous catheterisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002469-37-IT
• Lead Sponsor: CENTRO DI RIFERIMENTO ONCOLOGICO DI AVIANO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-12
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) patients > 18 years
2) Histologically confirmed diagnosis of cancer
3) Eligibility to permanent central venous catheter
4) Absence of cognitive impairment
5) ability to give informed consentg
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1)patients alreday treated with oppioids due to chronic oncologic pain
2)patients with previous nausea or vomiting due to oppioid treatment
3)patients with previous intolerance to fentanyl e.v. or transmucosal
4)chronic respiratory failure
5)renal or hepatic impairment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified