Clinical trial • Phase II • Musculoskeletal
NEFOPAM HYDROCHLORIDE for Postoperative pain after total knee arthroplasty
Phase II trial of NEFOPAM HYDROCHLORIDE for Postoperative pain after total knee arthroplasty.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Postoperative pain after total knee arthroplasty
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 31-05-2024
- First CTIS Authorization Date
- 30-07-2024
Trial design
Randomised, placebo: schweppes™ (placebo). test product: nefopam panpharma 20 mg/2 ml (product name indicates strength 20 mg/2 ml; productchangedescription: oral administratition). auxiliary/rescue analgesics: various marketed morphine products (morphine chlorhydrate/ sulfate; formulations listed) used as auxiliary treatment. doses and schedules not specified in the available data.-controlled Phase II trial across 1 site in France.
- Randomised
- Yes
- Comparator
- Placebo: Schweppes™ (placebo). Test product: NEFOPAM PANPHARMA 20 mg/2 mL (product name indicates strength 20 mg/2 mL; productChangeDescription: Oral administratition). Auxiliary/rescue analgesics: various marketed morphine products (MORPHINE CHLORHYDRATE/ SULFATE; formulations listed) used as auxiliary treatment. Doses and schedules not specified in the available data.
- Target Sample Size
- 50
Eligibility
Recruits 50 No vulnerable population selected. Only adults (Patient over 18). Consent is provided by the patient: "Patient having agreed to take part in the study and having signed the informed consent form." Subject information and informed consent form document is listed (L1_ SIS and IC). No assent provisions described..
- Pregnancy Exclusion
- Pregnancy or breastfeeding
- Vulnerable Population
- No vulnerable population selected. Only adults (Patient over 18). Consent is provided by the patient: "Patient having agreed to take part in the study and having signed the informed consent form." Subject information and informed consent form document is listed (L1_ SIS and IC). No assent provisions described.
Inclusion criteria
- {"criterion_text":"- Patient over 18.\n- Patient scheduled for primary PTG under spinal anesthesia, in the orthopedics department of the Croix-Rousse hospital.\n- Patient with an American Society of Anesthesiology (ASA) score between I and III.\n- Patient having agreed to take part in the study and having signed the informed consent form.\n- Patient entitled to social security benefits.\n- Patient willing to return for all study visits."}
Exclusion criteria
- {"criterion_text":"- Any contraindication for nefopam (known hypersensitivity, past medical history of seizures, urinary retention, benign prostate hyperplasia, angle glaucoma, ischemic cardiomyopathy waiting for revascularization, atrial fibrillation)\n- Medical conditions known to influence the pharmacokinetics of nefopam (chronic kidney failure with Glomerular Filtration Rate (GFR) <30mL/min/1,73m2, liver failure, current treatment with rifampicin, carbamazepine, azoles fungicides, macrolides)\n- Current treatment with benzodiazepines, anxiolytics, antidepressants, histamine H1 antagonists, neuroleptics, baclofen, thalidomide, barbiturates\n- Medical history of gastric or esophageal surgery.\n- Phenylketonuria\n- Pregnancy or breastfeeding\n- Past use of oral nefopam"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Total morphine consumption within 24h after the surgery.","definition_or_measurement_approach":"Total morphine consumption measured within 24 hours after surgery (primary objective: measure whether orally administered nefopam reduces morphine consumption at 24h after total knee replacement)."}
Secondary endpoints
- {"endpoint_text":"- Pressure Pain Threshold","definition_or_measurement_approach":""}
- {"endpoint_text":"- Punctate Pain Intensity","definition_or_measurement_approach":""}
- {"endpoint_text":"- Allodynia zone","definition_or_measurement_approach":""}
- {"endpoint_text":"- Pain intensity","definition_or_measurement_approach":""}
- {"endpoint_text":"- Self reported safety outcomes","definition_or_measurement_approach":""}
- {"endpoint_text":"- Measures of safety outcomes","definition_or_measurement_approach":""}
- {"endpoint_text":"- Plasmatic and cerebrospinal fluid concentration of nefopam","definition_or_measurement_approach":"Plasma and CSF concentrations measured (secondary objectives specify measurement 2 hours after oral administration)."}
- {"endpoint_text":"- Plasmatic and cerebrospinal fluid concentration of nefopam-beta-D-glucuronide","definition_or_measurement_approach":"Plasma and CSF concentrations measured (secondary objectives specify measurement 2 hours after oral administration)."}
- {"endpoint_text":"- Plasmatic and cerebrospinal fluid concentration of nefopam-N-oxyde","definition_or_measurement_approach":"Plasma and CSF concentrations measured (secondary objectives specify measurement 2 hours after oral administration)."}
- {"endpoint_text":"- Plasmatic and cerebrospinal fluid concentration of nefopam-N-demethyl","definition_or_measurement_approach":"Plasma and CSF concentrations measured (secondary objectives specify measurement 2 hours after oral administration)."}
- {"endpoint_text":"- Plasmatic and cerebrospinal fluid concentration of Nefopam hydrochloride","definition_or_measurement_approach":"Plasma and CSF concentrations measured (secondary objectives specify measurement 2 hours after oral administration)."}
- {"endpoint_text":"- Persistent postoperative pain - DN4 (or DN2 by phone)","definition_or_measurement_approach":"Persistent postoperative pain assessed using DN4 questionnaire (or DN2 by phone)."}
- {"endpoint_text":"- Persistent postoperative pain - DN4","definition_or_measurement_approach":"Persistent postoperative pain assessed using DN4 questionnaire."}
Recruitment
- Planned Sample Size
- 50
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent obtained from the patient (adult) who must agree and sign the informed consent form. Subject information and informed consent form document (L1_ SIS and IC) is listed. Study materials include French translations; consent appears to be in French. No assent process described.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 50
France
- Earliest CTIS Part Ii Submission Date
- 14-06-2024
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 682
- Number Of Sites
- 1
- Number Of Participants
- 50
Sites
- Site Name
- Hospital La Croix Rousse Hcl
- Department Name
- Anesthésie Réanimation
- Principal Investigator Name
- Frédéric Aubrun
- Principal Investigator Email
- frederic.aubrun@chu-lyon.fr
- Contact Person Name
- Frédéric Aubrun
- Contact Person Email
- frederic.aubrun@chu-lyon.fr
Sponsor
Primary sponsor
- Full Name
- Hospices Civils De Lyon
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- NEFOPAM PANPHARMA 20 mg/2 mL, solution injectable/pour perfusion
- Active Substance
- NEFOPAM HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Starting Dose
- 20 mg/2 mL (product strength stated)
- Investigational Product Name
- Schweppes™
- Modality
- Other
- Investigational Product Name
- Morphine products (MORPHINE (CHLORHYDRATE) AGUETTANT 10 mg/mL; MORPHINE (SULFATE) LAVOISIER 50 mg/ml; MORPHINE (CHLORHYDRATE) AGUETTANT 0,1 mg/mL; MORPHINE (CHLORHYDRATE) LAVOISIER 20 mg/ml)
- Active Substance
- MORPHINE HYDROCHLORIDE / MORPHINE SULFATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION / INJECTION
- Authorisation Status
- Authorised
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