Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
96
Countries
1
Sites
1
Pain
• Determine proportion of participants experiencing significant pain by intravenous injection of propofol or placebo
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Diseases [C] - Nervous System Diseases [C10], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 1 Sep 2025 → ongoing
- Decision date (initial)
- 2025-04-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Dept. of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Norway · University of Oslo, Institute of Clinical Medicine, Faculty of Medicine
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Dose response
• Determine proportion of participants experiencing significant pain by intravenous injection of propofol or placebo
Secondary objectives 5
- Determine pain intensity by intravenous injection fo propofol or placebo
- Determine pain intensity retrospectively scored, after procedure
- Determine the temporal evolution of pain intensity by intravenous injection of propofol/placebo
- Determine pain intensity during and after insertion of the intravenous cannula
- Determine level of sedation after cuff pressure release
Conditions and MedDRA coding
Pain
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10002182 | Analgesia | 10042613 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514307-34-00 | A randomized, double-blind crossover study to investigate propofol injection pain compared with placebo in healthy adult male and female participants. (PropPain) | Oslo University Hospital HF |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. The participant is overtly healthy as determined by medical evaluation including medical history and physical examination
- 2. Participant is ≥ 18 and < 50 years of age
- 3. Highly sensitive urine pregnancy test is negative for WOCBP
- 4. 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
Exclusion criteria 10
- 1. Known allergy or intolerance to the study intervention propofol
- 2. Known allergy or intolerance to eggs, soya or peanuts
- 3. BMI is <16 and ≥30
- 4. Use of analgesics or alcohol the last 24 h before study intervention
- 5. The participant is breastfeeding
- 6. The participant uses other medication(s) incompatible with the simultaneous use of propofol (e.g. benzodiazepines, hypnotics, narcotics, excessive alcohol use)
- 7. Participation in other clinical studies within the last two months before study intervention
- 8. Not meeting the rules of fasting according to the protocol
- 9. Any condition that in the view of the investigators would suggest that the patient is unable to comply with the study protocol and procedures.
- Known neurological illnesses (eg epilepsy)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • Proportion of participants with VAS≥30 mm (0-100mm)
Secondary endpoints 8
- • • Max electronic Visual Analog Scale (VAS) pain (0-100 mm)
- • Max Numeric Rating Scale (NRS) pain (0-10)
- • Time (seconds) to max electronic Visual Analog Scale (VAS) pain
- • Area under the curve (AUC) 0-1 min, 1-2 min, 2-3 min
- • Area under the curve VAS≥30 (AUCVAS≥30) 0-1 min, 1-2 min, 2-3 min
- • Curve shape of electronic Visual Analog Scale (VAS) pain (0-100 mm) by description of the curve (number of peaks)
- • Max Numeric Rating Scale (NRS) pain (0-10)
- • Richmond Agitation-Sedation Scale (RASS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Propolipid 10 mg/ml injeksjons-/infusjonsvæske, emulsjon
PRD534193 · Product
- Active substance
- Propofol
- Pharmaceutical form
- EMULSION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX10 — PROPOFOL
- Marketing authorisation
- 04-2932
- MA holder
- FRESENIUS KABI NORGE AS
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 50 ml millilitre(s)
- Max total dose
- 50 ml millilitre(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- 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
- Marianne Myhre
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Marianne Myhre
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 96 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2025-09-01 | 2025-09-10 |
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 20245143073401 | 5 |
| Recruitment arrangements (for publication) | AE-review - egenerklring | 1 |
| Recruitment arrangements (for publication) | AE-review - SMS | 1 |
| Recruitment arrangements (for publication) | Information flyer PropPain | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | NRS - smerteskaring | 1 |
| Recruitment arrangements (for publication) | Screening - Egenerklring om personopplysninger og helse | 1 |
| Recruitment arrangements (for publication) | Screening - for studiepersonell | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Propolipid | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_MS NO 20245143073400 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-11 | Norway | Acceptable 2025-03-31
|
2025-04-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-08 | Norway | Acceptable 2025-11-07
|
2025-11-07 |