Effentora® for Dyspnoea (EffenDys) - Fentanyl buccal tablet (FBT) for the relief of episodic dyspnoea (ED) in cancer patients: an open label, randomized, morphine-controlled, crossover, phase II trial

Phase 1

• Conditions: Patients with cancer suffering from episodes of dyspnoea (ED); Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2011-005797-32-DE
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-27
• Study Completion: 2014-10-29
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Principal inclusion criteria:
1.Histologically or cytologically proven cancer of any entity which is non-curable as judged by the referring physician or investigator
2.To be an inpatient during the study
3.Refractory dyspnoea – this study applies only to ‘refractory dyspnoea’ and is defined: a patient is still dyspnoic although the underlying disease (e.g. lung cancer) or cause of dyspnoea (e.g. pleural effusion) is treated optimal as judged by the referring physician or investigator
4.History of recurrent ED - ED is defined as an increase in dyspnoea occurring intermittently in patients with or without underlying continuous dyspnoea
5.Peak intensity of ED = 3 (NRS, 0-10)
6.Opioid tolerance for at least one day – opioid tolerance is defined: patient who receive per day at least 30mg oral morphine, 15mg oral oxycodone, 4mg oral hydromorphone, 12µg/h transdermal fentanyl or an analgetic equivalent of a different opioid or a different routes of application
7.Life expectancy of at least one month as judged by the referring physician or investigator

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 20

Exclusion Criteria

Principal exclusion criteria:
1.Uncontrolled dyspnoea (i.e. rapidly worsening dyspnoea requiring urgent medical or technical intervention)
2.Uncotrolled performance status (i.e. rapid deterioriation of performance status)
3.Consideration of any reason by the referring therapeutic team that the patient is not an appropriate participant of a clinical trial
4.Respiratory depression or preconditions with risk of respiratory depression
5.Acute abdomen or ileus or any situation that drug resoprtion is not possible
6.Renal dysfunction with creatinine clearance (eGFR) calculated as less than 25 ml/minute
7.Medical history of severe hepatic impairment
8.The use of fentanyl transmucosal products during the trial
9.The use of a monoamine oxidase inhibitors, SSRIs or SNRIs within the previous 14 days
10.Treatment with any other investigational drugs within the previous 10 days

Study & Design

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