Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
192
Countries
1
Sites
1
Dental care
The main aim of this study is to evaluate the efficacy of methoxyflurane (Penthrox®) in the management of pain in oral emergencies.
Key facts
- Sponsor
- Centre Hospitalier Regional Et Universitaire De Brest
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 14 Oct 2024 → 3 Oct 2025
- Decision date (initial)
- 2024-03-18
- 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: Prophylaxis
The main aim of this study is to evaluate the efficacy of methoxyflurane (Penthrox®) in the management of pain in oral emergencies.
Secondary objectives 9
- Evaluate the efficacy of methoxyflurane (Penthrox ®) in the proportion of patients with pain intensity <4/10 at T=15min after treatment
- Evaluate the immediate efficacy of methoxyflurane (Penthrox ®) in reducing pain in oral emergencies.
- Evaluate the persistence of the efficacy of methoxyflurane (Penthrox®) in reducing pain in oral emergencies
- Evaluate the effectiveness of methoxyflurane (Penthrox®) in reducing anxiety
- Evaluate the adverse effects of methoxyflurane use
- Evaluate the lack of local anesthetics used during treatment
- Evaluate patient satisfaction with methoxyflurane inhalers
- Evaluate the efficacy of methoxyflurane combined with another analgesic (subgroup analysis)
- Evaluate the effectiveness of methoxyflurane according to the type of emergency: infectious, traumatic or inflammatory (subgroup analysis)
Conditions and MedDRA coding
Dental care
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10044049 | Dental pain and sensation disorders | 10017947 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult patient (> 18 years)
- Conscious patient consulting an oral emergency department with pain assessed as moderate to severe NPS greater than or equal to 4
- Patient has social security affiliation or who beneficiary of such social security
- Patients who have given informed consent
Exclusion criteria 9
- Patients with a history of allergy to methoxyflurane or any of the components of Penthrox (take into account family history of severe allergic reactions)
- Patients with a history of malignant hyperthermia (known or genetic predisposition)
- Patients with hepatic impairment after use of methoxyflurane or halogenated hydrocarbon anesthesia
- Patients with severe renal failure
- Patients with altered level of consciousness, whatever the cause: head trauma, drug or alcohol abuse
- Patients with cardiovascular instability or respiratory depression
- Pregnant or breast-feeding patients. Therefore, a urine pregnancy test will be performed for all patients of childbearing age eligible to participate in the study
- Patients under legal protection (guardianship and curatorship) or deprived of liberty
- Patients unable to speak or read French fluently, unable to understand the principle of a numerical scale, anxiety and satisfaction questionnaires, and unable to cooperate with tests
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint was pain at baseline and at T=15min post-treatment, measured using a numerical pain scale (NPS) graded from 0 to 10
Secondary endpoints 9
- Pain intensity <4/10 (yes/no) at T=15min after treatment
- Measurement of pain intensity at T=7min (immediate efficacy)
- Measurement of pain intensity at T=40 minutes after treatment and just prior to treatment by the practitioner (persistence of efficacy)
- Anxiety, measured at inclusion and just before chairside treatment using a translated and adapted anxiety questionnaire (MDAS: modified dental anxiety scale)
- Report adverse events in both groups
- Measuring the amount of local anesthetic used during treatment
- Post-care satisfaction questionnaire
- Measurement of pain intensity at T=15min according to analgesic associated with methoxyflurane
- Measurement of pain intensity at T=15min according to type of emergency
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PENTHROX 3mL inhalation vapour, liquid
PRD3362263 · Product
- Active substance
- Methoxyflurane
- Pharmaceutical form
- INHALATION VAPOUR, LIQUID
- Route of administration
- INHALATION
- Max daily dose
- 6 ml millilitre(s)
- Max total dose
- 6 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BG09 — -
- Marketing authorisation
- PL 42467/0001
- MA holder
- MEDICAL DEVELOPMENTS UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- INHALATION
- Max daily dose
- 0 ml millilitre(s)
- Max total dose
- 0 ml millilitre(s)
- Max treatment duration
- 1 Week(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional Et Universitaire De Brest
- Sponsor organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Address
- 2 Avenue Marechal Foch
- City
- Brest
- Postcode
- 29200
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Prof. BOISRAME Sylvie
Public contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Prof. BOISRAME Sylvie
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 192 | 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 |
|---|---|---|---|---|---|
| France | 2024-10-14 | 2025-10-03 | 2024-10-14 | 2025-10-03 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-15 | France | Acceptable 2024-03-11
|
2024-03-18 |