Clinical trials: Pediatric Safety and Effectiveness
Common Cold, Influenza
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Other Acute Respiratory Viral Infections in Patients 3-6 y.o.
The purpose of this study is to determine whether Ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old…
- Trial name
- ACCORD (NCT02644018)
- Testing
- Imidazolyl ethanamide pentandioic acid
- Where
- 13 sites in Russia
- Volunteers
- 190 people
- Sponsor
- Valenta Pharm JSC
ICU Sedation
Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit
To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous IV infusion in pediatric subjects [≥ 45 weeks CGA (corrected gestational age) to <17 years old] requiring sedation under intensive care…
- Trial name
- NCT02757625
- Testing
- Dexmedetomidine hydrochloride
- Where
- 12 sites in Japan
- Volunteers
- 63 people
- Sponsor
- Pfizer
Pupillary Dilation Effect During Cycloplegic Refraction
Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects
This is a prospective randomized study compared with active control arm.
- Trial name
- NCT06609525
- Testing
- CTO0303-A, CTO0303-B, CTO0303-C
- Where
- South Korea
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Taejoon Pharmaceutical Co., Ltd.
Hemophilia A
Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A
Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form blood clots is missing or not present in sufficient levels.
- Trial name
- NCT01775618
- Testing
- BAY94-9027
- Where
- 37 sites in United States, Argentina and 15 more
- Volunteers
- 73 people
- Sponsor
- Bayer
Asthma
Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma
This study is a multicenter, stratified, randomized, active control, double-blinded, parallel-group comparative study with an open-label extension period.
- Trial name
- NCT02113436
- Testing
- FP/ SLM HFA MDI 50/25 mcg, FP HFA MDI 50 mcg
- Where
- 69 sites in Japan
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma
Study of Out of Specification for Tisagenlecleucel
This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product. Specifically, this study will evaluate the safety of CTL019 in the patients treated within the approved…
- Trial name
- NCT04094311
- Testing
- CTL019
- Where
- 55 sites in Canada, Japan
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
Polyarticular Juvenile Idiopathic Arthritis
An Observational Study to Assess Change in Disease Activity and Adverse Events of Adalimumab in Chinese Pediatric Participants With Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease affecting children, characterized by chronic synovitis with systemic multi-organ damage.
- Trial name
- NCT05411211
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- AbbVie
Anal Fissure
Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure
RECTIV® is an ointment containing 0.4% nitroglycerin (NTG) for the treatment of moderate to severe pain associated with chronic anal fissure approved in June 2011 by the US Food and Drug Administration (FDA) for adults.
- Trial name
- NCT01920074
- Testing
- Nitroglycerin Ointment 0.4%
- Where
- 6 sites in United States
- Sponsor
- Forest Laboratories
Endothelial Dysfunction, End-Stage Renal Disease
Ramipril vs. Amlodipine in Pediatric Hemodialysis Patients
The goal of this clinical trial is to learn if Ramipril works better than Amlodipine to reduce endothelial dysfunction in pediatric patients (aged 5-18 years) with end-stage kidney disease undergoing maintenance hemodialysis and…
- Conditions
- Endothelial Dysfunction, End-Stage Renal Disease, Pediatric Kidney Disease
- Trial name
- ADMA /PedsQL (NCT07879560)
- Testing
- Ramipril tablet, Amlodipine tablet
- Volunteers
- 50 people
- Sponsor
- Ain Shams University
Asthma
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
A study to evaluate the efficacy and safety of benralizumab administered subcutaneously in patients ≥ 6 to < 18 years of age with severe eosinophilic asthma, including a well-documented history of asthma exacerbations and…
- Trial name
- DOMINICA (NCT05692180)
- Testing
- Benralizumab
- Where
- 43 sites in United States, Argentina and 7 more
- Volunteers
- 94 people
- Sponsor
- AstraZeneca
Attention Deficit Hyperactivity Disorder
Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD
The purpose of the study is to compare atomoxetine hydrochloride and methylphenidate hydrochloride in pediatric patients with ADHD.
- Trial name
- NCT00486083
- Testing
- Atomoxetine Hydrochloride, Methylphenidate Hydrochloride
- Where
- 3 sites in China, Mexico and 1 more
- Volunteers
- 330 people
- Sponsor
- Eli Lilly and Company
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Neurofibromatosis 1, Plexiform Neurofibroma
Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1
FCN-159 (Luvometinib Tablets), an orally available and highly potent selective inhibitor of MEK1/2,demonstrated good tolerability and exhibited notable anti-tumor activity in pediatric pts with NF1-related PN in study…
- Conditions
- Neurofibromatosis 1, Plexiform Neurofibroma, NF1
- Trial name
- NCT07024394
- Testing
- Luvometinib Tablets
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Acute Myeloid Leukemia (AML)
Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age With Relapsed/Refractory CBFA2T3::GLIS2 AML
This trial will evaluate whether luveltamab tazevibulin is well tolerated and active against a rare form of AML carrying a particular genetic abnormality called CBFA2T3::GLIS2 that arises in infants and children.
- Trial name
- NCT06679582
- Testing
- Luveltamab tazevibulin
- Where
- 36 sites in United States, Austria and 7 more
- Volunteers
- 1 people
- Sponsor
- Sutro Biopharma, Inc.
Narcolepsy With Cataplexy
A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.
- Trial name
- NCT02221869
- Testing
- Xyrem
- Where
- 20 sites in United States, France and 2 more
- Volunteers
- 106 people
- Sponsor
- Jazz Pharmaceuticals
Pediatric Cancer, Li-Fraumeni Syndrome
Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer
This prospective, single-arm, multi-center clinical trial aims to explore and evaluate the efficacy and safety of arsenic trioxide combined with chemotherapy for pediatric cancer with p53 mutation.
- Conditions
- Pediatric Cancer, Li-Fraumeni Syndrome, p53 Mutations
- Trial name
- NCT06088030
- Testing
- Arsenic trioxide
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Yang Li
Epilepsy, Generalized Tonic-clonic Seizures
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic…
- Trial name
- NCT01292837
- Testing
- Levetiracetam
- Where
- 26 sites in Japan
- Volunteers
- 13 people
- Sponsor
- UCB Japan Co. Ltd.
Dermatitis, Atopic
An Efficacy and Safety Study of Tacrolimus Ointment in Pediatric Participants With Atopic Dermatitis
The purpose of this study is to evaluate the safety and efficacy of tacrolimus ointment in treating the signs and symptoms of moderate (medium level of seriousness) to severe (very serious, life threatening) atopic dermatitis (an…
- Trial name
- NCT01782729
- Testing
- Tacrolimus
- Where
- Vietnam
- Volunteers
- 30 people
- Sponsor
- Janssen-Cilag Ltd.,Thailand
Cough
Efficacy, Safety and Palatability of the Syrup "KalobaTuss® Children" for the Treatment of Cough in Children
Cough of children is one of the most frequent events for which parents ask for a medical consult and it is a true challenge for pediatrics during daily practice.
- Trial name
- KALOCOUGH (NCT04073251)
- Testing
- KalobaTuss children
- Where
- Italy
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Postoperative Nausea and Vomiting
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in…
- Trial name
- NCT01395901
- Testing
- Palonosetron, Ondansetron
- Where
- 44 sites in United States, Argentina and 6 more
- Volunteers
- 670 people
- Sponsor
- Helsinn Healthcare SA
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