Clinical trial • Not applicable • Respiratory
Ketoprofen for Pneumothorax
Not applicable trial of Ketoprofen for Pneumothorax.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Pneumothorax
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-04-2024
- First CTIS Authorization Date
- 30-07-2024
Trial design
Randomised, experimental arm: ketoprofen 100 mg 2x/day for 72 hours: a first injection of parenteral ketoprofen 100 mg followed by oral ketoprofen lp 100 mg for the next 5 doses. standard arm (placebo): placebo 2x/day for 72h: an initial injection of placebo (nacl 0.9% 100 ml parenterally) followed by oral placebo capsules for the next 5 doses.-controlled Not applicable trial in France.
- Randomised
- Yes
- Comparator
- Experimental Arm: Ketoprofen 100 mg 2x/day for 72 hours: a first injection of parenteral Ketoprofen 100 mg followed by oral Ketoprofen LP 100 mg for the next 5 doses. Standard Arm (placebo): placebo 2x/day for 72H: an initial injection of placebo (NaCl 0.9% 100 mL parenterally) followed by oral placebo capsules for the next 5 doses.
- Target Sample Size
- 358
- Trial Duration For Participant
- 365
Eligibility
Recruits 358 Minors are excluded. Patients under guardianship, curatorship or deprived of liberty are excluded. Written or oral informed consent is required from participants. No assent procedures or age-specific consent documents or languages are specified in the record..
- Pregnancy Exclusion
- Pregnant, parturient or breastfeeding patient
- Vulnerable Population
- Minors are excluded. Patients under guardianship, curatorship or deprived of liberty are excluded. Written or oral informed consent is required from participants. No assent procedures or age-specific consent documents or languages are specified in the record.
Inclusion criteria
- {"criterion_text":"- Pneumothorax for video-exclusive surgical indication With or without minor lung resection (atypical resection)\n- Age > or = 18 years old\n- Written or oral informed consent to participate in the study.\n- Affiliation to a social security scheme\n- 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
- {"criterion_text":"- Minor\n- Patient under guardianship, curatorship or deprived of liberty\n- patient who refuses to participate in the study\n- Contraindication to the use of NSAIDs\n- Contraindications to the use of NEFOPAM\n- Contraindications to the use of PARACETAMOL\n- Contraindications to the use of SODIUM CHLORIDE\n- Lactose intolerance\n- Hemopneumothorax\n- Purulent pleurisy\n- Polytraumatized\n- Pregnant, parturient or breastfeeding patient\n- Contraindications to the use of TRAMADOL\n- Curative anticoagulation"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Duration of pleural drainage (days).","definition_or_measurement_approach":"Measured as duration of pleural drainage in days."}
Secondary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Analgesia measured using Decimal Numerical Scale (END) at specified timepoints (post-operative H0, on leaving recovery room, H6, Day 1, Day 2)."}
- {"endpoint_text":"- Consumption of opioids (equivalent in mg of morphine)","definition_or_measurement_approach":"Measured as total opioid consumption expressed in mg morphine-equivalent."}
- {"endpoint_text":"- Recurrence of ipsilateral pneumothorax at 1 month, 6 months, 1 year","definition_or_measurement_approach":"Occurrence of ipsilateral pneumothorax assessed at 1 month, 6 months and 1 year follow-up."}
- {"endpoint_text":"- Efficiency of the gesture: - Drain productivity (mL) - Duration of bubbling (days)","definition_or_measurement_approach":"Drain productivity measured in mL; duration of bubbling measured in days."}
- {"endpoint_text":"- Post-operative medical and surgical complications : - Pneumonia during hospitalization (nominal) - duration of stay (days) - Need for re-intervention during stay (nominal)","definition_or_measurement_approach":"Complications recorded nominally (e.g., pneumonia), length of stay measured in days, and need for re-intervention recorded as nominal outcome."}
Recruitment
- Planned Sample Size
- 358
- Recruitment Window Months
- 48
- Consent Approach
- Written or oral informed consent is required from participants. Minors are excluded. No specific assent processes, age-specific documents, or languages are specified in the record.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 358
France
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 466
- Number Of Sites
- 4
- Number Of Participants
- 358
Sites
- Site Name
- Centre Hospitalier De Valenciennes
- Department Name
- Anesthesia and Intensive Care Unit
- Principal Investigator Name
- Fanny DEFRANCQ
- Principal Investigator Email
- defrancq-f@ch-valenciennes.fr
- Contact Person Name
- Fanny DEFRANCQ
- Contact Person Email
- defrancq-f@ch-valenciennes.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Anesthesia and Intensive Care Unit
- Principal Investigator Name
- Florent LEVIEL
- Principal Investigator Email
- leviel.florent@chu-amiens.fr
- Contact Person Name
- Florent LEVIEL
- Contact Person Email
- leviel.florent@chu-amiens.fr
- Site Name
- Clinique Victor Pauchet de Butler
- Department Name
- Anesthesia and Intensive Care Unit
- Principal Investigator Name
- Pierre HUETTE
- Principal Investigator Email
- huette.pierre@chu-amiens.fr
- Contact Person Name
- Pierre HUETTE
- Contact Person Email
- huette.pierre@chu-amiens.fr
- Site Name
- CHU De Rouen
- Department Name
- Anesthesia and Intensive Care Unit
- Principal Investigator Name
- Jean SLIM
- Principal Investigator Email
- jean.selim@chu-rouen.fr
- Contact Person Name
- Jean SLIM
- Contact Person Email
- jean.selim@chu-rouen.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire Amiens Picardie
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- KETOPROFEN (injection and oral)
- Active Substance
- Ketoprofen
- Modality
- Small molecule
- Routes Of Administration
- Parenteral injection; Oral (prolonged-release tablet)
- Route
- Parenteral then oral
- Authorisation Status
- Authorised/marketed
- Starting Dose
- Initial parenteral Ketoprofen 100 mg, then oral Ketoprofen LP 100 mg
- Dose Levels
- 100 mg
- Frequency
- 2x/day for 72 hours
- Maximum Dose
- 200 mg/day
- Investigational Product Name
- SODIUM CHLORIDE (placebo injection)
- Active Substance
- Sodium chloride (0.9% NaCl)
- Modality
- Small molecule
- Routes Of Administration
- IV injection, IV infusion
- Route
- Parenteral (IV)
- Starting Dose
- NaCl 0.9% 100 mL parenterally (initial placebo injection)
- Frequency
- Single initial injection as placebo followed by oral placebo dosing
- Investigational Product Name
- CELLULOSE, MICROCRYSTALLINE (oral placebo)
- Active Substance
- Cellulose, microcrystalline
- Modality
- Other
- Routes Of Administration
- Oral
- Route
- Oral
- Starting Dose
- Oral placebo capsules (details not specified)
- Frequency
- Following initial injection, oral placebo capsules for next 5 doses
- Investigational Product Name
- TRAMADOL
- Active Substance
- Tramadol
- Modality
- Small molecule
- Routes Of Administration
- Oral (capsule)
- Route
- Oral
- Maximum Dose
- 300 mg/day
- Investigational Product Name
- NEFOPAM
- Active Substance
- Nefopam
- Modality
- Small molecule
- Routes Of Administration
- Infusion (solution for injection)
- Route
- Parenteral (infusion)
- Maximum Dose
- 60 mg/day
- Investigational Product Name
- PARACETAMOL
- Active Substance
- Paracetamol
- Modality
- Small molecule
- Routes Of Administration
- Infusion (solution for infusion)
- Route
- Parenteral (infusion)
- Maximum Dose
- 4000 mg/day
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