Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
12
Countries
1
Sites
1
Nasotracheal intubation
Comparison of cocaine, lidocaine/xylometazoline and saline for intranasal analgesia - A blinded triple crossover study
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 1 Jul 2024 → 27 Aug 2024
- Decision date (initial)
- 2024-05-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Comparison of cocaine, lidocaine/xylometazoline and saline for intranasal analgesia - A blinded triple crossover study
Conditions and MedDRA coding
Nasotracheal intubation
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age 18 years or above
- Proficient in spoken and written Danish
- Healthy volunteers (no active diagnoses)
- Negative hCG urine stix for women of childbearing potential
Exclusion criteria 5
- Known nasal malformation
- Known coagulopathy
- Current antithrombotic treatment
- Self-reported epistaxis occurring more than once a month
- Symptoms of a common cold within the past week
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Self reported pain felt during the procedure reported on a visual analogue scale of 0-100.
Secondary endpoints 5
- Self reported pain felt after one minute of tolerating the nasal tube reported on a visual analogue scale of 0-100.
- Acoustic rhinometry measurement with the use of the RhinoScan SRE2000, Interacoustics A/S, Assens, Denmark.
- Video-evaluated assessment of the degree of vasoconstriction on the nasal mucosa.
- Saliva samples analyzed for cocaine’s main metabolite benzoylecgonine.
- Blood samples analyzed for cocaine.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
Lidokain SAD injektionsvæske, opløsning
PRD349021 · Product
- Active substance
- Lidocaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 5 mg/Kg milligram(s)/kilogram
- Max total dose
- 5 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- 16309
- MA holder
- AMGROS I/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
N01B · Product
- Pharmaceutical form
- -
- Route of administration
- INTRANASAL USE
- Max daily dose
- 1.5 mg/Kg milligram(s)/kilogram
- Max total dose
- 1.5 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01B — ANESTHETICS, LOCAL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Zymelin ukonserveret, næsespray, opløsning
PRD9261301 · Product
- Active substance
- Xylometazoline Hydrochloride
- Pharmaceutical form
- NASAL SPRAY, SOLUTION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R01AA07 — XYLOMETAZOLINE
- Marketing authorisation
- 30564
- MA holder
- ORIFARM HEALTHCARE A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumklorid isotonisk "SAD", injektionsvæske, opløsning
PRD349415 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 2 ml millilitre(s)
- Max total dose
- 2 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 16404
- MA holder
- AMGROS I/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Mo Haslund Larsen
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Mo Haslund Larsen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rigshospitalet
Department of Anaesthesiology, Blegdamsvej 9, 2100, Copenhagen Oe
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 |
|---|---|---|---|---|---|
| Denmark | 2024-07-01 | 2024-08-27 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-46368
- Sponsor became aware
- 2024-09-16
- Date of breach
- 2024-07-01
- Submission date
- 2024-09-16
- Member states concerned
- Denmark
- Categories
- Protocol
- Areas impacted
- Other
- Benefit-risk balance changed
- No
- Description
- Due to a typing error, the volumes of the trial drugs lidocaine and xylometazoline were interchanged. This error occurred in the production of the Standard Operating Proceudre (SOP) for medicine preparation, where the dosages were erroneously typed.
At all visits where participants were allocated to receive 0.5 ml xylometazoline and 1.5 ml lidocaine they instead received 1.5 ml xylometazoline and 0.5 ml lidocaine. - Sponsor actions
- The breach was discovered during data analysis after completion of the trial and correction of the breach was therefore not possible. The dosages are correctly noted in the trial protocol and erroneously in the Standard Operating Proceudre (SOP) which all trial medicine dosages was confirmed with. Our investigation has concluded and identified the typing error in the Standard Operating Proceudre (SOP) as the origin of the breach. No more data needs to be collected for this study, so no measures are taken to prevent further implications of the breach in this study.
| Organisation | City | Country | Type |
|---|---|---|---|
| Rigshospitalet | Copenhagen Oe | Denmark | Other |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-09 | Denmark | Acceptable 2024-05-13
|
2024-05-13 |