Clinical trials: Pediatric Safety and Effectiveness
Kidney Transplantation
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.
- Trial name
- NCT00154206
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Sialorrhea, Neurodevelopmental Disorders
Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Efficacy and Safety of Sialanar Plus orAl rehabiLitation Against Placebo Plus Oral Rehabilitation for chIldren and Adolescents With seVere Sialorrhoea and Neurodisabilties,
Double blind, placebo-controlled, randomised trial, multicentre in France with open-label tolerability phase. The double-blind placebo-controlled study duration will be scheduled for 3 months with the final visit of the…
- Trial name
- SALIVA (NCT04873115)
- Testing
- Sialanar, Oral Rehabilitation
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Proveca Pharma Limited
Venous Thromboembolism
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
- Trial name
- EINSTEIN Jr (NCT02234843)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of Care
- Where
- 109 sites in United States, Argentina and 26 more
- Volunteers
- 500 people
- Sponsor
- Bayer
Chronic Severe Plaque-type Psoriasis
Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis
This was a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with severe chronic plaque psoriasis.
- Trial name
- NCT02471144
- Testing
- Experimental : Secukinumab low dose, Experimental: Secukinumab high dose, Active Comparator: Etanercept
- Where
- 46 sites in United States, Belgium and 17 more
- Volunteers
- 162 people
- Sponsor
- Novartis Pharmaceuticals
Ankle Sprain
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).
- Trial name
- NCT01037816
- Testing
- FS-67 Patch
- Where
- 23 sites in United States
- Volunteers
- 252 people
- Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
Type 1 Diabetes Mellitus
Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus
This study will assess the safety and efficacy of secukinumab on the preservation of pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.
- Trial name
- NCT02044848
- Testing
- Secukinumab
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Novartis Pharmaceuticals
Neuroectodermal Tumors, Rhabdomyosarcoma
Trial of Afatinib in Pediatric Tumours
Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part. The trial will consist of 2 parts: 1. Dose finding part to determine the MTD 2.
- Trial name
- NCT02372006
- Testing
- afatinib
- Where
- 28 sites in United States, Australia and 10 more
- Volunteers
- 56 people
- Sponsor
- Boehringer Ingelheim
Atopic Dermatitis
Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis
Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in Japanese pediatric patients with atopic…
- Trial name
- NCT00231998
- Testing
- Pimecrolimus
- Where
- Japan
- Volunteers
- 240 people
- Sponsor
- Novartis
Injections, Intravenous, Administration, Intravenous
A Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population.
- Trial name
- NCT03145519
- Testing
- Vasofix Certo Catheter, OptiVein Catheter
- Where
- Estonia
- Volunteers
- 188 people
- Sponsor
- Optomeditech Oy
Anxiety Neuroses, Anxiety States, Neurotic
A Study in Pediatric Participants With Generalized Anxiety Disorder
The purpose of this study is to find out if duloxetine [30-120 milligrams (mg)] given once a day by mouth for 10 weeks to children and adolescents, is better than placebo when treating Generalized Anxiety Disorder (GAD).
- Conditions
- Anxiety Neuroses, Anxiety States, Neurotic, Neuroses, Anxiety
- Trial name
- NCT01226511
- Testing
- Duloxetine
- Where
- 24 sites in United States, Mexico and 1 more
- Volunteers
- 281 people
- Sponsor
- Eli Lilly and Company
Venous Thromboembolism (VTE), Pulmonary Embolism
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE.
- Conditions
- Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
- Trial name
- NCT02798471
- Testing
- Edoxaban, Standard of Care
- Where
- 140 sites in United States, Argentina and 32 more
- Volunteers
- 290 people
- Sponsor
- Daiichi Sankyo
Neuromuscular Blockade
Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial
The purpose of this clinical trial is to prove that the administration of sugammadex at a dose of 4 mg/kg for counteracting deep blockage [without train-of-four (TOF) ratio response and post-tetanic count (PTC) < of 2 induced and…
- Trial name
- SUGAPED-01 (NCT01809886)
- Testing
- Sugammadex, Neostigmine
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
X-Linked Hypophosphatemia
Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH
The primary objective of this study is to evaluate the effect of KRN23 (burosumab) therapy in improving rickets in children with XLH compared with active control (oral phosphate/active vitamin D).
- Trial name
- NCT02915705
- Testing
- burosumab, Oral Phosphate Supplement, active vitamin D
- Where
- 16 sites in United States, Australia and 5 more
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin, Inc.
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
Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease
A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease
This study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to evaluate the incidence of serious adverse events (SAEs) within 12, 26, and 52 weeks after treatment; as well as the…
- Trial name
- NCT07564505
- Testing
- Adalimumab Solution for Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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"
Relapse B Acute Lymphoblastic Leukemia, Refactory Childhood Acute Lymphoblastic Leukemia
Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)
A Phase 1 clinical trial to evaluate the safety and early efficacy of Chimeric Antigen Receptor T-cell (CAR T-cell) with IL-7Rα signaling targeting CD19 in children with relapsed and refractory B-cell Acute Lymphoblastic Leukemia…
- Trial name
- CMD63 (NCT07078929)
- Testing
- CD19-IL7Ra CAR-T cells
- Where
- 3 sites in Thailand
- Volunteers
- 16 people
- Sponsor
- Chulalongkorn University
PIK3CA-related Overgrowth Spectrum (PROS)
EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)
This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).
- Trial name
- NCT06997588
- Testing
- Alpelisib
- Where
- 39 sites in United States, Australia and 9 more
- Volunteers
- 140 people
- Sponsor
- Novartis Pharmaceuticals
Suspected or Documented Gram-negative Bacterial Infection
Safety, Tolerability, Efficacy and Pharmacokinetics of Imipenem/Cilastatin/Relebactam (MK-7655A) in Pediatric Participants With Gram-negative Bacterial Infection (MK-7655A-021)
The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial…
- Trial name
- NCT03969901
- Testing
- IMI/REL, Active Control, Oral Switch
- Where
- 67 sites in United States, Bulgaria and 16 more
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Lice Infestations
Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion.
- Trial name
- NCT00244439
- Testing
- MALG, Ovide (malathion) lotion 0.05%, Permethrin 1%
- Where
- 6 sites in United States
- Volunteers
- 360 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.