Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
300
Countries
1
Sites
1
trauma to the lower or upper limb
to determine the efficacy of the use of sublingual sufentanil 30mcg in emergency patients admitted for moderate to severe pain following a single trauma compared to the standard management currently in the department between T0 and T0 + 60 min.
Key facts
- Sponsor
- University Hospital Of Clermont-Ferrand
- Participant type
- Patients
- 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], Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 22 Apr 2025 → ongoing
- Decision date (initial)
- 2025-03-21
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
to determine the efficacy of the use of sublingual sufentanil 30mcg in emergency patients admitted for moderate to severe pain following a single trauma compared to the standard management currently in the department between T0 and T0 + 60 min.
Secondary objectives 4
- “Safety” objectives: by evaluating and comparing potential adverse effects between randomization groups: hypotension, bradycardia, respiratory depression, sweating, drowsiness, nausea and/or vomiting, dizziness.
- Compare between the randomization groups the variation of pain by the verbal numerical scale between T0 and T0 + 15 min, T0 +30 min, T0 + 45 min, T0 + 60 min, T0 + 120 min and T0 + 180 min.
- Compare hemodynamic parameters between randomization groups: blood pressure, pulse, oxygen saturation, respiratory rate.
- Compare between the randomization groups the quality assessment of pain management felt by the patient (of the product and of pain management in general)
Conditions and MedDRA coding
trauma to the lower or upper limb
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10033447 | Pain in limb | 10028395 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Prise en charge de la douleur Après randomisation : Prise de sufentanil sublingual 30mcg ou "standard of care" pour la prise d'antalgiques
|
Randomised Controlled | None | Bras « expérimental » Sufentanil: Bras « expérimental » : le patient recevra du sufentanil sublingual 30mcg Bras « standard of care »: Bras « standard of care » : le patient bénéficiera de la prise en charge habituelle prévue dans le protocole d’anticipation d’antalgiques par l’infirmière d’orientation et d’accueil à l’admission au Service d’Accueil des Urgences |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- adult patient
- Patient with a numeric pain rating scale ≥ 4
- Pain of monotraumatic origin in the upper or lower limb
- Glasgow = 15
- SaO2 > 95% in ambient air
Exclusion criteria 11
- Polytrauma
- Analgesic treatment within 4 hours prior to admission (except paracetamol)
- Woman of childbearing age not using effective contraception, or declaring herself pregnant or at risk of pregnancy or breastfeeding woman, or positive pregnancy test upon inclusion
- Patient requiring intravenous line placement upon admission
- Contraindication or allergy to one of the molecules in the analgesic protocol
- Refusal to participate
- Known drug abuse or psychiatric disorders
- Known oxygen dependency or COPD
- Not affiliated with social security
- Patient under guardianship, curatorship, deprived of liberty or under legal protection
- Patient does not speak or read French
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- the variation in pain rating measured by the verbal numerical scale between T0 and T0+60 minutes
Secondary endpoints 4
- The tolerance profile will be assessed by analyzing the occurrence of any adverse event, mainly (hypotension, bradycardia, respiratory depression, sweating, drowsiness, nausea and/or vomiting, dizziness)
- Variation of pain rating measured by verbal numerical scale between T0 and T0+15min; T0+30 min; T0+45 min; T0 + 60 min T0+120 min; T0+180 minutes, Variation of pain rating measured by verbal numerical scale between T0 and TEVmax. Pain intensity assessed at different times, T0, T0 + 15min, T0 + 30min, T0 + 45min, T0 + 60min, T0 + 120min, T0 + 180min.
- Measurement of variations in hemodynamic parameters: blood pressure, pulse, oxygen saturation, respiratory rate.
- At the end of the study at T0 + 180 min, patients will be asked to give their assessment via a verbal satisfaction scale ranging from 0 "Very dissatisfied" to 10 "Very satisfied": - of the permucosal product tested using a product assessment questionnaire. - Of the pain management in general
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Dzuveo 30 micrograms sublingual tablet
PRD9336907 · Product
- Active substance
- Sufentanil
- Substance synonyms
- OX27
- Pharmaceutical form
- SUBLINGUAL TABLET
- Route of administration
- ORAL
- Max daily dose
- 90 µg microgram(s)
- Max total dose
- 90 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH03 — SUFENTANIL
- Marketing authorisation
- EU/1/18/1284/001
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 10
ACUPAN 20 mg/2 mL, solution injectable
PRD945133 · Product
- Active substance
- Nefopam
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BG06 — NEFOPAM
- Marketing authorisation
- 34009 324 217 5 6
- MA holder
- BIOCODEX
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD429943 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 4 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- 34009 321 816 5 0
- MA holder
- OPELLA HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PARACETAMOL AGUETTANT 10 mg/ml, solution pour perfusion
PRD10481650 · Product
- Active substance
- Paracetamol
- Substance synonyms
- ACETAMINOPHEN
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 4 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- 3400958668562
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TRAMADOL ARROW 100 mg/2 mL, solution injectable/pour perfusion
PRD9891145 · Product
- Active substance
- Tramadol Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AX02 — TRAMADOL
- Marketing authorisation
- 63777286
- MA holder
- EUGIA PHARMA (MALTA) LTD
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CODOLIPRANE 500 mg/30 mg, comprimé
PRD972384 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 4 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE51 — PARACETAMOL, COMBINATIONS EXCL. PSYCHOLEPTICS
- Marketing authorisation
- 34009 269 839 3 2
- MA holder
- OPELLA HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MORPHINE (CHLORHYDRATE) RENAUDIN 10 mg/ml, solution injectable
PRD2938263 · Product
- Active substance
- Morphine Hydrochloride
- Substance synonyms
- MORPHINI HYDROCHLORIDUM
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 15 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- 34009 566 964 7 5
- MA holder
- LABORATOIRE RENAUDIN
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KETOPROFENE AGUETTANT 100 mg, solution pour perfusion
PRD10482595 · Product
- Active substance
- Ketoprofen
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M01AE03 — KETOPROFEN
- Marketing authorisation
- 34009 419 161 7 5
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IXPRIM 37,5 mg/325 mg, comprimé pelliculé
PRD11476258 · Product
- Active substance
- Tramadol Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 8 U unit(s)
- Max total dose
- 8 U unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AJ13 — -
- Marketing authorisation
- 34009 551 022 9 8
- MA holder
- LABORATOIRES GRÜNENTHAL S.A.S.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KALINOX 50 %/ 50 % Gas zur medizinischen Anwendung, druckverdichtet
PRD376215 · Product
- Active substance
- Nitrous Oxide
- Substance synonyms
- NITROGEN DIOXIDE, DINITROGENII OXIDUM, NITROGEN MONOXIDE, LAUGHING GAS
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION GAS
- Max daily dose
- 1 h hour
- Max total dose
- 1 h hour
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AX63 — -
- Marketing authorisation
- 1-30414
- MA holder
- AIR LIQUIDE SANTE INTERNATIONAL
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD429743 · Product
- Active substance
- Paracetamol
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 4 g gram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- 34009 579 380 9 3
- MA holder
- OPELLA HEALTHCARE FRANCE SAS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Hospital Of Clermont-Ferrand
- Sponsor organisation
- University Hospital Of Clermont-Ferrand
- Address
- 58 Rue Montalembert
- City
- Clermont-Ferrand
- Postcode
- 63000
- Country
- France
Scientific contact point
- Organisation
- University Hospital Of Clermont-Ferrand
- Contact name
- Lise Laclautre
Public contact point
- Organisation
- University Hospital Of Clermont-Ferrand
- Contact name
- Lise Laclautre
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 300 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
University Hospital Of Clermont-Ferrand
SAMU - SMUR Urgences, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
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 | 2025-04-22 | 2025-04-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 21 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PROTOCOL FOR PUBLICATION_2024-519217-64-00_SubSUF-ER | 3 |
| Protocol (for publication) | D1_PROTOCOL FOR PUBLICATION_2024-519217-64-00_SubSUF-ER v3_tracked | 3 |
| Protocol (for publication) | D1_PROTOCOL SIGNATURE_2024-519217-64-00_V4_20260219_SubSUF-ER | 4 |
| Protocol (for publication) | D1_PROTOCOL_2024-519217-64-00_SubSUF-ER | 4 |
| Protocol (for publication) | D1_PROTOCOL_2024-519217-64-00_SubSUF-ER v3_tracked | 3 |
| Protocol (for publication) | D1_PROTOCOL_2024-519217-64-00_SubSUF-ER v4_tracked | 4 |
| Recruitment arrangements (for publication) | K1_RECRUITMENT ARRANGEMENTS_2024-519217-64-00_SubSUF-ER | 2 |
| Subject information and informed consent form (for publication) | L1_SIS AND ICF PATIENT_2024-519217-64-00_SubSUF-ER | 2 |
| Subject information and informed consent form (for publication) | L1_SIS AND ICF PATIENT_2024-519217-64-00_SubSUF-ER v2_tracked | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC ACUPAN IV_2024-519217-64-00_SubSUF-ER | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC CODOLIPRANE_2024-519217-64-00_SubSUF-ER | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC DOLIPRANE 1000_2024-519217-64-00_SubSUF-ER | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC DOLIPRANE 500_2024-519217-64-00_SubSUF-ER | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IXPRIM_2024-519217-64-00_SubSUF-ER | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC KETOPROFENE IV_2024-519217-64-00_SubSUF-ER | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC MEOPA_2024-519217-64-00_SubSUF-ER | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC MORPHINE_2024-519217-64-00_SubSUF-ER | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC PARACETAMOL IV_2024-519217-64-00_SubSUF-ER | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC SUFENTANIL_2024-519217-64-00_SubSUF-ER | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC TRAMADOL_2024-519217-64-00_SubSUF-ER | 1 |
| Synopsis of the protocol (for publication) | D1_PROTOCOL SYNOPSIS FOR PUBLICATION_2024-519217-64-00_SubSUF-ER | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-13 | France | Acceptable 2025-03-14
|
2025-03-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-13 | France | Acceptable 2026-04-16
|
2026-04-24 |