266
Participants
Start Date
March 31, 2023
Primary Completion Date
July 31, 2027
Study Completion Date
July 31, 2027
Nalmefene
"Week 1: 18 mg/d~Week 2:~1. In the absence of ARs or in the presence of grade 1 or 2 ARs, 36 mg/d~2. In the presence of grade 3 ARs, 18 mg/d~3. In the presence of grade 4 ARs, treatment will be stopped immediately.~Week 3 to week 5:~1. In case of acceptable safety profile at the 18mg/d dosage during week 2, the treatment will be maintained at the same dosage~2. In the presence of sustained grade 3 ARs at the 18mg/d dosage during week 2, the treatment will be stopped.~3. In case of acceptable safety profile at the 36mg/d dosage during week 2, the treatment will be maintained at the same dosage~4. In the presence of grade 3 ARs at the 36mg/d dosage during week 2, the treatment dosage will be decreased at 18mg/d~5. Whatever the dosage during week 2, in the presence of grade 4 ARs, the treatment will be stopped immediately."
Placebo
"Week 1: 1 tablet/d~Week 2:~1. In the absence of ARs or in the presence of grade 1 or 2 ARs, 2 tablets/d~2. In the presence of grade 3 ARs, 1 tablet/d~3. In the presence of grade 4 ARs, the treatment will be stopped immediately.~Week 3 to week 5:~1. In case of acceptable safety profile at the dosage of 1 tablet/d during week 2, the treatment will be maintained at the same dosage~2. In the presence of sustained grade 3 ARs at the dosage of 1 tablet/d during week 2, the treatment will be stopped.~3. In case of acceptable safety profile at the dosage of 2 tablets/d during week 2, the treatment will be maintained at the same dosage~4. In the presence of grade 3 ARs at the dosage of 2 tablets/d during week 2, the treatment dosage will be decreased at 1 tablet/d~5. Whatever the dosage during week 2, in the presence of grade 4 ARs, the treatment will be stopped immediately."
RECRUITING
CH de La Rochelle, La Rochelle
NOT_YET_RECRUITING
CHU de Dijon, Dijon
RECRUITING
CHRU de Brest, Brest
RECRUITING
CHU de Nîmes, Nîmes
RECRUITING
CHU de Bordeaux, Bordeaux
NOT_YET_RECRUITING
CHU de Montpellier, Montpellier
RECRUITING
CHRU de Tours, Tours
RECRUITING
CHU de Clermont Ferrand, Clermont-Ferrand
RECRUITING
Hôpitaux Universitaires de Strasbourg, Strasbourg
RECRUITING
Hospices Civils de Lyon, Lyon
RECRUITING
Hôpital Paul Brousse, Villejuif
NOT_YET_RECRUITING
CHU de Besançon, Besançon
RECRUITING
CHU de Nantes, Nantes
Nantes University Hospital
OTHER