Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruiting
Participants planned
358
Countries
1
Sites
5
pleurodesis surgery for cure of pneumothorax
show the non-inferiority, in terms of drainage time, of NSAIDs after pleurodesis surgery for the cure of pneumothorax
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 7 May 2025 → ongoing
- Decision date (initial)
- 2024-07-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- PHRC-I 2019 du GIRCI Nord-Ouest
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
show the non-inferiority, in terms of drainage time, of NSAIDs after pleurodesis surgery for the cure of pneumothorax
Secondary objectives 4
- The efficiency of analgesia and opioid consumption
- The risk of recurrence
- the efficiency of the gesture
- Postoperative medico-surgical complications.
Conditions and MedDRA coding
pleurodesis surgery for cure of pneumothorax
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | ketoprofen versus placebo Patients in the experimental arm receive Ketoprofen 100 mg 2x/d for 72 hours:
- A first injection of parenteral Ketoprofen 100 mg
- followed by oral Ketoprofen LP 100mg for the next 5 doses
Patients in the control arm receive placebo 2x/d for 72H:
- an initial injection of placebo: NaCl 0.9% 100mL parenterally
- followed by oral placebo capsules for the next 5 doses.
|
Randomised Controlled | Double | [{"id":181836,"code":4,"name":"Analyst"},{"id":181840,"code":2,"name":"Investigator"},{"id":181839,"code":3,"name":"Monitor"},{"id":181837,"code":5,"name":"Carer"},{"id":181838,"code":1,"name":"Subject"}] | Standard Arm: placebo 2x/d for 72H: - an initial injection of placebo: NaCl 0.9% 100mL parenterally - followed by oral placebo capsules for the next 5 doses. Experimental Arm: Ketoprofen 100 mg 2x/d for 72 hours: - A first injection of parenteral Ketoprofen 100 mg - followed by oral Ketoprofen LP 100mg for the next 5 doses |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Pneumothorax for video-exclusive surgical indication With or without minor lung resection (atypical resection)
- Age > or = 18 years old
- Written or oral informed consent to participate in the study.
- Affiliation to a social security scheme
- Highly effective contraception for women of childbearing age (combined hormonal contraception (estrogen and progesterone) combined with ovulation inhibition (oral, intra-vaginal, transdermal), hormonal contraception (progesterone only) combined with ovulation inhibition (oral, injectable, implantable), intrauterine device, hormone-releasing intrauterine system, bilateral fallopian tube occlusion, vasectomized partner, sexual abstinence, etc.). )
Exclusion criteria 14
- Minor
- Contraindications to the use of NEFOPAM
- Contraindications to the use of PARACETAMOL
- Contraindications to the use of SODIUM CHLORIDE
- Lactose intolerance
- Hemopneumothorax
- Purulent pleurisy
- Polytraumatized
- Pregnant, parturient or breastfeeding patient
- Patient under guardianship, curatorship or deprived of liberty
- patient who refuses to participate in the study
- Contraindication to the use of NSAIDs
- Contraindications to the use of TRAMADOL
- Curative anticoagulation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Duration of pleural drainage (days).
Secondary endpoints 5
- Efficiency of analgesia: - Decimal Numerical Scale (END) for cough at post-operative H0 - END at rest at post-operative H0 - END at rest and cough upon leaving the recovery room - END at rest and cough at H6, D1, D2
- Consumption of opioids (equivalent in mg of morphine)
- Recurrence of ipsilateral pneumothorax at 1 month, 6 months, 1 year
- Efficiency of the gesture: - Drain productivity (mL) - Duration of bubbling (days)
- Post-operative medical and surgical complications : - Pneumonia during hospitalization (nominal) - duration of stay (days) - Need for re-intervention during stay (nominal)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB08374MIG · Substance
- Active substance
- Ketoprofen
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08374MIG · Substance
- Active substance
- Ketoprofen
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INJECTION, IV INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12626MIG · Substance
- Active substance
- Cellulose, Microcrystalline
- Pharmaceutical form
- ORAL POWDER
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
SUB11210MIG · Substance
- Active substance
- Tramadol
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09183MIG · Substance
- Active substance
- Nefopam
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 8000 millilitre(s)/kilogram
- 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
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- ABOU ARAB Ossama
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Marwa Khamari
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 358 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier De Valenciennes
Anesthesia and Intensive Care Unit, 114 Avenue Desandrouin, 59300, Valenciennes
Hôpital Privé Arras Les Bonnettes
Anesthesia and Intensive Care Unit, 2 rue du Dr Forgeois, 62000, ARRAS
Clinique Victor Pauchet de Butler
Anesthesia and Intensive Care Unit, 2 Avenue D Irlande, 80090, Amiens
CHU De Rouen
Anesthesia and Intensive Care Unit, 147 Avenue Du Marechal Juin, 76230, Bois-Guillaume
Centre Hospitalier Universitaire Amiens Picardie
Anesthesia and Intensive Care Unit, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens 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 | 2025-05-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-511226-32-00 | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults TC | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ketoprofene 100mg pour perfusion | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ketoprofene secable a liberation prolongee | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2024-511226-32-00 | 2.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-22 | France | Acceptable 2024-07-22
|
2024-07-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-22 | France | Acceptable 2026-05-05
|
2026-05-28 |