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

Phase II clinical study on the efficacy and safety of procedural analgesia of oral transmucosal fentanyl citrate in oncologic patients eligible to permanent central venous catheter

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002469-37-IT

Enrollment

Registered

2012-09-12

Start date

2012-09-28

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer patients eligible to permanent central venous catheter due to chemotherapeutic treatment MedDRA version: 15.0 Level: PT Classification code 10053377 Term: Central venous catheterisation System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: EFFENTORA*4CPR MUCOSAOS 100MCG Pharmaceutical Form: Oromucosal capsule INN or Proposed INN: FENTANYL CITRATE Concentration unit: µg microgram(s) Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluation of efficacy of fentanyl transmucosal citrate of improving analgesia during Central Venous Catheterization;Secondary Objective: evaluation of safety of fentanyl transmucosal citrate of improving analgesia during Central Venous Catheterization;Primary end point(s): Analgesic efficacy of transmucosal fentanyl citrate;Timepoint(s) of evaluation of this end point: 10 minutes after the end of central venous chateterization	—

Measure

Time frame

Main Objective: evaluation of efficacy of fentanyl transmucosal citrate of improving analgesia during Central Venous Catheterization;Secondary Objective: evaluation of safety of fentanyl transmucosal citrate of improving analgesia during Central Venous Catheterization;Primary end point(s): Analgesic efficacy of transmucosal fentanyl citrate;Timepoint(s) of evaluation of this end point: 10 minutes after the end of central venous chateterization

—

Secondary

Measure	Time frame
Secondary end point(s): Safety of transmucosal fentanyl citrate;Timepoint(s) of evaluation of this end point: 10 minutes after the end of central venous chateterization and 4 hours after drug administration	—

Countries

Italy

Contacts

Public ContactDirezione Scientifica

Centro di Riferimento Oncologico (CRO) - IRCCS

dirscienti@cro.it0434 659282

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026