Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
22
Countries
1
Sites
1
Subjects having local anesthesia for dental procedures.
To investigate the analgesic efficacy of a lidocaine-prilocaine combination compared to lidocaine alone in dental procedures.
Key facts
- Sponsor
- Pharmavax AS
- 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
- 9 Dec 2024 → 31 Dec 2024
- Decision date (initial)
- 2024-11-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Pharmavax AS
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To investigate the analgesic efficacy of a lidocaine-prilocaine combination compared to lidocaine alone in dental procedures.
Secondary objectives 4
- To investigate the analgesic efficacy of lidocaine-prilocaine combination compared to lidocaine alone in dental procedures using an ice test.
- To investigate the pain experienced by the participant during a standard pocket probing.
- To investigate participant experience of the anaesthesia (subject measured outcome).
- To evaluate the safety and tolerability of a lidocaine-prilocaine combination compared to lidocaine.
Conditions and MedDRA coding
Subjects having local anesthesia for dental procedures.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10078542 | Dental local anaesthesia | 100000004865 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants aged ≥18 and ≤ 65.
- Written informed consent to participate in the study.
- Participants with red hair or with at least one parent and/or grandparent with red hair and/or genetic sibling from same parents with red hair.
Exclusion criteria 5
- History or presence of hypersensitivity or allergy to lidocaine (or prilocaine or other local anesthetics (amid type or sodium metabisulfite), a history of anaphylactic or anaphylactoid reactions, or a history of other allergy that, in the opinion of the investigator, contraindicates participation.
- Participants with known thyrotoxicosis.
- Participants with severe heart disease, including tachycardia.
- Local infection in the area of injection.
- Participants with congenital or idiopathic methemoglobinemia.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Successful pulpal anaesthesia measured by two consecutive 64/64 readings without any participant response, within 10 min with an electric pulp tester.
Secondary endpoints 3
- Successful pulpal anaesthesia measured by the participants cold sensation during an ice test applied to the treated area.
- Subject’s assessment of successful soft tissue anaesthesia (yes/no) during a standard pocket procedure.
- Participant experience of anaesthesia on a scale from 1-5.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Citanest® Dental Octapressin 30 mg/ml + 0,03 IE/ml
PRD444442 · Product
- Active substance
- Prilocaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 1.8 ml millilitre(s)
- Max total dose
- 1.8 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB54 — PRILOCAINE, COMBINATIONS
- Marketing authorisation
- 5068
- MA holder
- DENTSPLY DETREY
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Xylocain ®Dental adrenalin 20 mg/ml + 12,5 mikrog/ml Injeksjonsvæske, oppløsning i sylindretter
PRD444443 · Product
- Active substance
- Epinephrine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 5.4 ml millilitre(s)
- Max total dose
- 5.4 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB52 — LIDOCAINE, COMBINATIONS
- Marketing authorisation
- 2165
- MA holder
- DENTSPLY DETREY
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pharmavax AS
- Sponsor organisation
- Pharmavax AS
- Address
- Rosenholmveien 25
- City
- Trollaasen
- Postcode
- 1414
- Country
- Norway
Scientific contact point
- Organisation
- Pharmavax AS
- Contact name
- Co-ordinating investigator
Public contact point
- Organisation
- Pharmavax AS
- Contact name
- Co-ordinating investigator
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Smerud Medical Research International AS ORG-100008599
|
Oslo, Norway | Code 12, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ended | 22 | 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 | 2024-12-09 | 2024-12-31 | 2024-12-10 | 2024-12-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Clinical study report SUM-81228
|
2025-05-05T11:37:39 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Clinical study report - lay summary | 2025-05-05T11:37:46 | Submitted | Laypersons Summary of Results |
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 4075 4700A CSR lay summary v1-0_Redacted | 1 |
| Protocol (for publication) | D1_Protocol_2024-515965-32-00_redacted | 4.0 |
| Protocol (for publication) | D4_Patient facing document_Questionnaire | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ advertisement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-and-ICF_adults | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Citanest-Dental-Octapressin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Xylocain-Dental-Adrenalin | 1 |
| Summary of results (for publication) | 4075 4700A CSR v1-0_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis_NO-2024-515965-32-00 | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-13 | Norway | Acceptable 2024-11-25
|
2024-11-27 |