Clinical trial • Phase III • Gastroenterology|Rare Disease
Triamcinolone acetonide for Esophageal strictures following esophageal atresia repair
Phase III trial of Triamcinolone acetonide for Esophageal strictures following esophageal atresia repair. 110 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology|Rare Disease
- Trial Disease
- Esophageal strictures following esophageal atresia repair
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 14-11-2023
- First CTIS Authorization Date
- 11-01-2024
Trial design
Phase III trial across 7 sites in Netherlands, Denmark, France and others.
- Target Sample Size
- 110
- Trial Duration For Participant
- 182
Eligibility
Recruits 110 paediatric patients.
- Pregnancy Exclusion
- Patients of child bearing potential
- Vulnerable Population
- Paediatric patients (children). Written informed consent required from both parents or legal representatives, if applicable (subject information and informed consent forms for parents available).
Inclusion criteria
- {"criterion_text":"- Children with EA type C who underwent primary anastomotic surgery within the first days of life"}
- {"criterion_text":"- Age ≥3 months at the time of the study dilatation"}
- {"criterion_text":"- In need of a 3rd or 4th dilatation"}
- {"criterion_text":"- Written informed consent by both parents or legal representatives, if applicable"}
Exclusion criteria
- {"criterion_text":"- Age <3 months"}
- {"criterion_text":"- Known inability from previous dilatations to use an endoscope with a size of 5.8 mm"}
- {"criterion_text":"- No parental written informed consent"}
- {"criterion_text":"- Patients of child bearing potential"}
- {"criterion_text":"- Patients with severe coagulation disorders, or with ongoing anticoagulation treatment"}
- {"criterion_text":"- Hypersensitivity to the active substance or to one of the excipients"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The total number of dilatations within 28 days interval needed per patient during the study period, i.e. from the day of the study dilatation until 6 months later.","definition_or_measurement_approach":"Measured as the total number of dilatations per patient within 28-day intervals during the study period, counted from the day of the study dilatation until 6 months later."}
Recruitment
- Planned Sample Size
- 110
- Recruitment Window Months
- 110
- Consent Approach
- Written informed consent required from both parents or legal representatives, if applicable. Subject information and informed consent form documents for parents (L1_SIS and ICF parents) are provided; protocol synopses and translations are available (English, French, Dutch, Swedish).
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 110
Netherlands
- Earliest CTIS Part Ii Submission Date
- 06-12-2023
- Latest Decision Or Authorization Date
- 15-01-2024
- Processing Time Days
- 40
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- John Vlot
- Principal Investigator Email
- john.vlot@erasmusmc.nl
- Contact Person Name
- John Vlot
- Contact Person Email
- john.vlot@erasmusmc.nl
Denmark
- Earliest CTIS Part Ii Submission Date
- 21-12-2023
- Latest Decision Or Authorization Date
- 17-01-2024
- Processing Time Days
- 27
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Odense University Hospital
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Súsanna Petersen
- Principal Investigator Email
- Susanna.Petersen@rsyd.dk
- Contact Person Name
- Súsanna Petersen
- Contact Person Email
- Susanna.Petersen@rsyd.dk
- Site Name
- Copenhagen University Hospital
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Jacob Oehlenschlæger
- Principal Investigator Email
- jacob.oehlenschlaeger.01@regionh.dk
- Contact Person Name
- Jacob Oehlenschlæger
- Contact Person Email
- jacob.oehlenschlaeger.01@regionh.dk
France
- Earliest CTIS Part Ii Submission Date
- 06-12-2023
- Latest Decision Or Authorization Date
- 05-02-2024
- Processing Time Days
- 61
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Frederic Gottrand
- Principal Investigator Email
- Frederic.GOTTRAND@chu-lille.fr
- Contact Person Name
- Frederic Gottrand
- Contact Person Email
- Frederic.GOTTRAND@chu-lille.fr
Sweden
- Earliest CTIS Part Ii Submission Date
- 06-12-2023
- Latest Decision Or Authorization Date
- 11-01-2024
- Processing Time Days
- 36
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Lund University Hospital
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Erik Omling
- Principal Investigator Email
- erik.omling@med.lu.se
- Contact Person Name
- Erik Omling
- Contact Person Email
- erik.omling@med.lu.se
- Site Name
- Karolinska University Hospital
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Jan Svensson
- Principal Investigator Email
- jan.f.svensson@regionstockholm.se
- Contact Person Name
- Jan Svensson
- Contact Person Email
- jan.f.svensson@regionstockholm.se
Finland
- Earliest CTIS Part Ii Submission Date
- 06-12-2023
- Latest Decision Or Authorization Date
- 12-01-2024
- Processing Time Days
- 37
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- HUS-yhtymae
- Department Name
- Pediatric Surgery
- Principal Investigator Name
- Janne Suomine
- Principal Investigator Email
- Janne.Suominen@hus.fi
- Contact Person Name
- Janne Suomine
- Contact Person Email
- Janne.Suominen@hus.fi
Sponsor
Primary sponsor
- Full Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Third parties
- {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Kenacort-A 10, suspensie voor injectie 10 mg/ml
- Active Substance
- Triamcinolone acetonide
- Modality
- Small molecule
- Routes Of Administration
- Local injection
- Route
- LOCAL INJECTION
- Authorisation Status
- Authorised (marketing authorisation present)
- Maximum Dose
- 10 mg
- Investigational Product Name
- Kenacort-T 40 mg/ml injektionsvätska, suspension
- Active Substance
- Triamcinolone acetonide
- Modality
- Small molecule
- Routes Of Administration
- Local injection
- Route
- LOCAL INJECTION
- Authorisation Status
- Authorised (marketing authorisation present)
- Maximum Dose
- 10 mg
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