Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
26
Countries
1
Sites
1
Pain
Determine the analgesic efficacy of icatibant vs placebo in a propofol injection pain model
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2025-08-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- University of Oslo, Institute of Clinical Medicine, Faculty of Medicine · Dept. of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Norway
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Efficacy, Safety
Determine the analgesic efficacy of icatibant vs placebo in a propofol injection pain model
Secondary objectives 1
- Determine maximal pain intensity with icatibant vs placebo in a propofol injection pain model
Conditions and MedDRA coding
Pain
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10002182 | Analgesia | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- The participant is overtly healthy as determined by medical evaluation including medical history and physical examination
- Participant is ≥ 18 and < 50 years of age
- Highly sensitive urine pregnancy test is negative for WOCBP
- The participant must give a signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- The participant has participated in the PropPain study (EU CT 2024-514307-34-01) and obtained a max electronic Visual Analog Scale (VAS) pain ≥30 mm
Exclusion criteria 10
- Known allergy or intolerance to the study intervention icatibant, or to propofol
- Known allergy or intolerance to eggs, soya or peanuts
- Known neurological illness (e.g. epilepsy)
- BMI is <16 and ≥30
- Use of analgesics or alcohol the last 24 h before the study interventions
- The participant is breastfeeding
- The participant uses other medication(s) incompatible with the simultaneous use of propofol (e.g. benzodiazepines, hypnotics, narcotics, excessive alcohol use)
- Participation in other clinical studies within the last two months before study intervention (except the related study mentioned above)
- Not meeting the rules of fasting according to the protocol
- Any condition that in the view of the investigators would suggest that the patient is unable to comply with the study protocol and procedures.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Area under the curve of Visual Analog Scale pain ≥ 30 mm (0-100 mm) - AUCVAS≥30
Secondary endpoints 1
- Max electronic Visual Analog Scale (VAS) pain (0-100 mm)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11873056 · Product
- Active substance
- Propofol
- Substance synonyms
- 2,6-Bis(PROPAN-2-YL)PHENOL, ICI-35868, DISOPROFOL
- Pharmaceutical form
- EMULSION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 0.35 mg/kg milligram(s)/kilogram
- Max total dose
- 0.7 mg/kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- 37162
- MA holder
- FRESENIUS KABI AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP51825813 · ATC
- Active substance
- Icatibant
- Route of administration
- INTRAVENOUS
- Max daily dose
- 23 µg/Kg microgram(s)/kilogram
- Max total dose
- 23 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B06AC02 — ICATIBANT
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Dilution (with Saline 0.9%)
Placebo 1
Natriumklorid ”B. Braun”, infusionsvæske, opløsning
PRD11829629 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 5 ml millilitre(s)
- Max total dose
- 5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 13341
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Bjarte Onsrud
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Bjarte Onsrud
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Authorised, recruitment pending | 26 | 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 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 20255213544200 | 2 |
| Protocol (for publication) | D4_Patient facing documents | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Propolipid | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Firazyr | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Icatibant Glenmark | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Icatibant Newbury | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Icatibant Sandoz | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Icatibant Teva | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_MS NO 20255213544200 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-05 | Norway | Acceptable 2025-08-13
|
2025-08-14 |