Overview
Sponsor-declared trial summary
To evaluate the effectiveness and tolerability of fentanyl in PCSC, compared with the administration of morphine in BSC on demand, for the treatment of refractory dyspnea in patients hospitalized for acute decompensation of HF.
To evaluate the effectiveness and tolerability of fentanyl in PCSC, compared with the administration of morphine in BSC on demand, for the treatment of refractory dyspnea in patients hospitalized for acute decompensation of HF.
Key facts
- Sponsor
- Fundacio Assistencial De Mutua De Terrassa Fpc
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-01-27
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Hospital Universitari Mutua Terrassa
External identifiers
- EU CT number
- 2024-520025-36-00
- EudraCT number
- 2020-003971-16
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate the effectiveness and tolerability of fentanyl in PCSC, compared with the administration of morphine in BSC on demand, for the treatment of refractory dyspnea in patients hospitalized for acute decompensation of HF.
Secondary objectives 1
- o evaluate the effectiveness and tolerability of fentanyl in PCSC, compared with the administration of morphine in BSC on demand, for the treatment of refractory dyspnea in patients hospitalized for acute decompensation of HF.
Conditions and MedDRA coding
To evaluate the effectiveness and tolerability of fentanyl in PCSC, compared with the administration of morphine in BSC on demand, for the treatment of refractory dyspnea in patients hospitalized for acute decompensation of HF.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Age equal to or greater than 18 years. 2. Hospitalized at the Mútua Terrassa University Hospital in the internal medicine units and complex chronic patient unit, due to HF decompensation, of any etiology. Patients may be included only once during each hospital admission; In case of re-entry for the same reason, they may be included again. 3. In optimized treatment of their HF decompensation at the discretion of the specialist doctor responsible for the case. 4. Refractory dyspnea persists despite treatment. 5. Has received two or more doses of 3 mg of SC morphine on demand for dyspnea in the previous 24 hours, as indicated by the responsible physician. 6. The patient gives informed consent that attests to his or her correct understanding of the purposes and procedures of the study and his desire to voluntarily participate in the study. In the event that the patient, due to his or her personal conditions or clinical situation, cannot grant consent, it will be the family member or primary caregiver who receives the explanations and grants consent. 7. It is expected that the patient will be able to complete questionnaires on the effectiveness and tolerability of the drugs administered. Otherwise, it is expected that the family member or the main reference caregiver will be able to complete these questionnaires.
Exclusion criteria 1
- 1. History of alcohol or drug abuse. 2. Allergy to fentanyl or morphine 3. Contraindication to opioid use: Known hypersensitivity to morphine. Patients with respiratory depression or severe obstructive respiratory disease. Patients with acute bronchial asthma. Patients treated with monoamine oxidase inhibitors or during the 14 days following the suspension of such treatment. Patients with acute and/or severe liver disease. Patients with head injury; increased intracranial pressure. Patients in coma. Patients with spasms of the renal and biliary tract. Patients with acute alcoholism. Patients at risk of paralytic ileus. Patients with ulcerative colitis. Patients in shock. In case of infection at the injection site and in patients with severe coagulation disorders, epidural or intrathecal administration is contraindicated. 4. Concomitant treatment with opioids for other causes. 5. Simultaneous participation in another study or clinical trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Reduction in the average daily intensity of dyspnea is the main criterion of effectiveness. The intensity of dyspnea is evaluated by the patient himself using a Verbal Numerical Scale (EVN) and a Visual Analogue Scale (VAS) of dyspnea 56. The effectiveness of the treatment is evaluated by comparing the EVN and VAS of dyspnea in the first evaluation or 0h with the EVN and VAS of dyspnea in the following consecutive evaluations or 24h, 48h and 72h.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB07597MIG · Substance
- Active substance
- Fentanyl
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3 g/ml gram(s)/millilitre
- Max total dose
- 3 g/ml gram(s)/millilitre
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fentanilo Medlink 50 microgramas/ml solução injetável
PRD10250377 · Product
- Active substance
- Fentanyl
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSIÓN INTRAVENOSA
- Max daily dose
- 3 mg/m3 milligram(s)/cubic meter
- Max total dose
- 3 mg/m3 milligram(s)/cubic meter
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- N01AH01 — FENTANYL
- Marketing authorisation
- 5847942
- MA holder
- MEDLINK PHARMA LDA.
- MA country
- Portugal
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacio Assistencial De Mutua De Terrassa Fpc
- Sponsor organisation
- Fundacio Assistencial De Mutua De Terrassa Fpc
- Address
- Calle De San Antonio No 32
- City
- Terrassa
- Postcode
- 08221
- Country
- Spain
Scientific contact point
- Organisation
- Fundacio Assistencial De Mutua De Terrassa Fpc
- Contact name
- [email protected]
Public contact point
- Organisation
- Fundacio Assistencial De Mutua De Terrassa Fpc
- Contact name
- [email protected]
Sponsor responsibilities
- Article 77 compliance
- Fundacio Assistencial De Mutua De Terrassa Fpc
- Contact point sponsor
- Fundacio Assistencial De Mutua De Terrassa Fpc
- Article 77 implementation
- Fundacio Assistencial De Mutua De Terrassa Fpc
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 28 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | FEMODRIC 20201106 | 1 |
| Recruitment arrangements (for publication) | FEMODRIC 20201106 | 1 |
| Subject information and informed consent form (for publication) | HOJA DE INFORMACION AL PACIENTE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | FT_41764_farmaco | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | Spain | Acceptable with conditions 2025-01-27
|
2025-01-27 |