interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).
The EU Clinical Trials Register currently displays
44256
clinical trials with a EudraCT protocol, of which
7344
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see
Frequently Asked Questions ).
Full Title: Oral Ibuprofene versus oral kethorolac for children with musculoskeletal injury: a double blind randomized controlled study.
Medical condition: Pain is present in 78% of overall accesses in pediatric emergency rooms and, in most cases, it is acute and secondary to musculoskeletal trauma. Fifthy percent of patients report moderate to severe...
Full Title: Less opioids after major abdominal surgery in young infants using wound catheter infusion with local anesthetics: a randomized controlled trial.
Medical condition: Children < 1 year of age undergoing major open abdominal surgery.
Disease:
Version
SOC Term
Classification Code
Term
Level
20.1
10010331 - Congenital, familial and genetic disorders
10021298
Ileal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10010526
Congenital large intestinal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10002120
Anal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10010626
Congenital small intestinal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10062022
Intestinal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10013812
Duodenal atresia
PT
20.1
10010331 - Congenital, familial and genetic disorders
10028210
Multiple gastrointestinal atresias
PT
Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18
Full Title: A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Bacterial Skin and Sk...
Medical condition: Acute bacterial skin and skin structure infection. For Cohort 5 (from birth to less than 3 months) also patients with sepsis are allowed.
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10021881 - Infections and infestations
10066412
Staphylococcus aureus skin infection
LLT
20.0
10021881 - Infections and infestations
10037633
Pyoderma (skin infection)
LLT
20.1
10021881 - Infections and infestations
10040873
Skin infection aggravated
LLT
20.0
10021881 - Infections and infestations
10040872
Skin infection
PT
20.0
10021881 - Infections and infestations
10040875
Skin infection pyogenic
LLT
20.0
10021881 - Infections and infestations
10040874
Skin infection NOS
LLT
20.1
10021881 - Infections and infestations
10066409
Staphylococcal skin infection
PT
20.0
10021881 - Infections and infestations
10040047
Sepsis
PT
Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18
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• EEA CTAs: Date study was authorised to proceed • Outside EU/EEA: Date study was submitted in EudraCT