Clinical trials: Pediatric Disease
Asthma, Bronchoconstriction
Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol in Pediatric Subjects
The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in pediatric subjects with asthma
- Trial name
- NCT00685347
- Testing
- Levalbuterol HFA MDI, Racemic Albuterol
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- Sumitomo Pharma America, Inc.
Neuroblastoma, Ewing's Sarcoma
Use of Racotumomab in Patients With Pediatric Tumors Expressing N-glycolylated Gangliosides
This study will be carried out in children with diagnosis of cancer with tumors known to express N-glycolylated gangliosides. The disease must be resistant to conventional therapy.
- Conditions
- Neuroblastoma, Ewing's Sarcoma, Wilm's Tumor, Retinoblastoma
- Trial name
- NCT01598454
- Testing
- racotumomab
- Where
- Argentina
- Volunteers
- 15 people
- Sponsor
- Laboratorio Elea Phoenix S.A.
Infection, Meningitis
Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF
Prospective, multi-site, study to evaluate the diagnosis rate of DNA and RNA sequencing of cerebrospinal fluid for identification of pathogens directly in patients who have already had a spinal tap to evaluate for infection and…
- Trial name
- PIPSEC (NCT03796546)
- Where
- 3 sites in United States
- Volunteers
- 71 people
- Sponsor
- IDbyDNA, Inc.
Tinea Pedis, Tinea Cruris
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch.
- Trial name
- NCT01712360
- Testing
- NAFT500 (pediatric), NAFT600 (pediatric), NAFT500 (adult)
- Where
- 4 sites in United States, Dominican Republic and 1 more
- Volunteers
- 56 people
- Sponsor
- Merz North America, Inc.
Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
Pediatric Arthritis Study of Certolizumab Pegol
A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA).
- Trial name
- PASCAL (NCT01550003)
- Testing
- Certolizumab Pegol (CZP)
- Where
- 36 sites in United States, Argentina and 5 more
- Volunteers
- 193 people
- Sponsor
- UCB BIOSCIENCES GmbH
Overactive Bladder, Neurogenic Detrusor Overactivity
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects From 3 to Less Than 12 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)
The purpose of the study is to evaluate the pharmacokinetics (PK) of mirabegron oral suspension after single dose administration in children with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB).
- Trial name
- NCT02526979
- Testing
- mirabegron
- Where
- 3 sites in Denmark, Poland
- Volunteers
- 9 people
- Sponsor
- Astellas Pharma Europe B.V.
Crohn's Disease, Ulcerative Colitis
A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
The purpose of this study is to evaluate the long-term safety and clinical status of pediatric patients with Inflammatory Bowel Disease (IBD).
- Conditions
- Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Inflammatory Bowel Diseases
- Trial name
- DEVELOP (NCT00606346)
- Testing
- Anti TNF therapy including infliximab, No Biologics
- Where
- 62 sites in United States, Canada
- Volunteers
- 4,970 people
- Sponsor
- Janssen Biotech, Inc.
Encephalitis
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51…
- Trial name
- NCT01041573
- Testing
- IC51 Japanese Encephalitis, Havrix®720, Prevnar
- Where
- 2 sites in Philippines
- Volunteers
- 1,869 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Crohn's Disease
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention.
- Trial name
- AMAY (NCT05509777)
- Testing
- Mirikizumab
- Where
- 81 sites in United States, Austria and 14 more
- Volunteers
- 90 people
- Sponsor
- Eli Lilly and Company
Growth Disorders
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK
This is a National, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospital in the UK and…
- Trial name
- ECOS UK (NCT01263457)
- Testing
- Easypod
- Where
- 6 sites in United Kingdom
- Volunteers
- 191 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Epilepsies, Partial
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study: The frequency of treatment related adverse events.
- Trial name
- NCT01441401
- Testing
- gabapentin
- Volunteers
- 82 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants
The primary objectives of this study are to evaluate the safety, tolerability and steady-state PK and confirm the dose of EVG/r in HIV-1 infected, antiretroviral treatment-experienced children 4 weeks to <18 years of age.
- Trial name
- NCT01923311
- Testing
- EVG, Background regimen
- Where
- 11 sites in United States, Italy and 4 more
- Volunteers
- 31 people
- Sponsor
- Gilead Sciences
Bipolar Depression
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as…
- Trial name
- NCT06372964
- Testing
- Lumateperone
- Where
- 68 sites in United States, Colombia and 2 more
- Volunteers
- 384 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Non Alcoholic Steatohepatitis
Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)
The study was being conducted in order to assess the pharmacokinetics and the safety of elafibranor following once daily administration of two dose levels of elafibranor (80 milligrams [mg] and 120mg) during 3 months in children…
- Trial name
- NCT03883607
- Testing
- Elafibranor 80mg, Elafibranor 120mg
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Genfit
Neurofibromatosis 1, Plexiform Neurofibroma
Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1
FCN-159 is a highly active MEK1/2 inhibitor that was designed, synthesized and screened on the basis of the structure of trametinib.
- Conditions
- Neurofibromatosis 1, Plexiform Neurofibroma, NF1
- Trial name
- NCT04954001
- Testing
- FCN-159
- Where
- 14 sites in United States, China and 1 more
- Volunteers
- 160 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Rett Syndrome
ANAVEX2-73 Study in Pediatric Patients With Rett Syndrome
ANAVEX2-73-RS-003 is a Phase 2/3, double-blind, randomized, placebo-controlled dose escalation safety, tolerability and efficacy study in patients 5-17 years of age with RTT using endpoints including multiple clinical and…
- Trial name
- EXCELLENCE (NCT04304482)
- Testing
- ANAVEX2-73 oral liquid
- Where
- 12 sites in Australia, Canada and 1 more
- Volunteers
- 92 people
- Sponsor
- Anavex Life Sciences Corp.
Atopic Dermatitis
A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
The purpose of this study is to evaluate the safety, tolerability and the pharmacokinetics (PK) of topical ruxolitinib cream applied to pediatric subjects (age ≥ 2 to 17 years) with atopic dermatitis (AD).
- Trial name
- NCT03257644
- Testing
- Ruxolitinib phosphate cream
- Where
- 23 sites in United States
- Volunteers
- 70 people
- Sponsor
- Incyte Corporation
Hypertension
A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension
Drugs used to treat hypertension in adults should also be effective in treating high blood pressure in infants and children. This study will test the safety and efficacy of valsartan in lowering blood pressure in children 1 - 5…
- Trial name
- NCT00171028
- Testing
- valsartan
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Novartis
Atopic Dermatitis
Cutivate Lotion HPA Axis Pediatric Study
A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.
- Trial name
- NCT00546000
- Testing
- Fluticasone propionate 0.05% lotion
- Where
- 10 sites in United States
- Volunteers
- 56 people
- Sponsor
- Fougera Pharmaceuticals Inc.
Allergic Rhinitis
Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)
The purpose of this study is to evaluate the efficacy and safety of Beclomethasone dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).
- Trial name
- NCT01783548
- Testing
- BDP Nasal Aerosol
- Where
- 63 sites in United States
- Volunteers
- 547 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
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