Fentanyl for the treatment of dsypnea in patients with chronic heart failure

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-000712-33-AT

Enrollment

Unknown

Registered

2008-05-15

Start date

2008-05-13

Completion date

Unknown

Last updated

2016-11-07

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

Conditions

Symptomatic treatment of dyspnea induced by chronic heart failure MedDRA version: 9.1 Level: LLT Classification code 10013963 Term: Dyspnea

Interventions

Trade Name: Actiq 200 µg Pharmaceutical Form: Buccal tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: chronic heart failure NYHA IIIb, burden dyspnea, informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: no informed consent, severe organ failures, contraindication for opioids

Design outcomes

Primary

Measure	Time frame
Main Objective: Tolerability of buccal fentanyl in patients with acute dyspnea resulted from chronic heart failure;Secondary Objective: Effectiveness of fentanyl in the symptomatic treatment of dyspnea ;Primary end point(s): 1. Feasibilty of the study in patients with chronic heart failure NYHA IIIb 2. Compliance and tolerabilty of the use of buccal fentanyl in patients with acute dysnpnea 3. Effectiveness of buccal fentanyl in patients with acute dyspnea caused by chronic heart failure regarding the time of relieve and the improvement of the physical performance	—

Measure

Time frame

Main Objective: Tolerability of buccal fentanyl in patients with acute dyspnea resulted from chronic heart failure;Secondary Objective: Effectiveness of fentanyl in the symptomatic treatment of dyspnea ;Primary end point(s): 1. Feasibilty of the study in patients with chronic heart failure NYHA IIIb 2. Compliance and tolerabilty of the use of buccal fentanyl in patients with acute dysnpnea 3. Effectiveness of buccal fentanyl in patients with acute dyspnea caused by chronic heart failure regarding the time of relieve and the improvement of the physical performance

—

Countries

Austria

Outcome results

None listed

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