Clinical trials: Pediatric Safety and Effectiveness
Operative Sedation of Pediatric, Operative Sedation of Adolescent Patients
A Trial of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients
The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.
- Trial name
- NCT07036419
- Testing
- Remimazolam Tosilate for injection, Propofol Injection
- Where
- China
- Volunteers
- 249 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Nervous System Diseases
Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan
The purpose of this study is to assess the efficacy, safety and pharmacokinetics of MHOS/SHP615 administered buccally in children with status epilepticus (convulsive) in a healthcare setting.
- Trial name
- NCT03336645
- Testing
- SHP615
- Where
- 23 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Shire
Atopic Dermatitis
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Pediatric Atopic Dermatitis
This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.
- Trial name
- NCT02748993
- Testing
- PAC-14028 Cream 0.1%, PAC-14028 Cream 0.3%, PAC-14028 Cream 1.0%
- Where
- 3 sites in South Korea
- Volunteers
- 56 people
- Sponsor
- Amorepacific Corporation
Children and Adolescents Aged 6 to 18 With Moderate-to-Severe Plaque Psoriasis
The Efficacy and Safety of SHR-1314 in the Treatment of Pediatric Patients of Age 6 to <18 Years With Moderate to Severe Plaque Psoriasis
The purpose of this study is to assess efficacy, safety of subcutaneous SHR-1314 in pediatric patients of age 6 to <18 years with moderate-to-Severe plaque psoriasis
- Trial name
- NCT06833307
- Testing
- SHR-1314
- Where
- 2 sites in China
- Volunteers
- 90 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
SCN2A-DEE, Epilepsy
A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
The goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.
- Trial name
- NCT05737784
- Testing
- PRAX-222 - Initial Dose, PRAX-222 - Initial Ascending Doses, PRAX-222 - Optional Ascending Doses
- Where
- 3 sites in United States, Brazil
- Volunteers
- 60 people
- Sponsor
- Praxis Precision Medicines
Diarrhea-Associated Hemolytic Uremic Syndrome, Pediatric Kidney Disease
A Study to Assess Safety, Efficacy, and Pharmacokinetics of INM004 in Pediatric Patients With STEC-HUS
Hemolytic Uremic Syndrome (HUS) is a foodborne disease which mainly affects children. It is caused by Escherichia coli bacteria, which release a toxin called Shiga toxin within the body.
- Conditions
- Diarrhea-Associated Hemolytic Uremic Syndrome, Pediatric Kidney Disease, Hemolytic-Uremic Syndrome
- Trial name
- NCT05569746
- Testing
- INM004, SoC
- Where
- 16 sites in Argentina
- Volunteers
- 57 people
- Sponsor
- Inmunova S.A.
Glaucoma, Ocular Hypertension
Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension
The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks.
- Trial name
- NCT00061542
- Testing
- BETOPTIC S (betaxolol HCl), Timolol Gel-forming Solution (TGFS)
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- Alcon Research
Plastic Bronchitis, Protein-Losing Enteropathies
Inhaled Tissue Plasminogen Activator for Acute Plastic Bronchitis
Plastic bronchitis (PB) is a rare, most often pediatric disease characterized by the formation of obstructive airway casts primarily composed of fibrin.
- Conditions
- Plastic Bronchitis, Protein-Losing Enteropathies, Healthy
- Trial name
- PLATyPuS (NCT02315898)
- Testing
- Treatment-inhaled tPA
- Where
- 6 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Attention-Deficit/Hyperactivity Disorder (ADHD)
Study to Evaluate NRCT-101SR in Pediatric Subjects With ADHD
To evaluate the efficacy and safety of NRCT-101SR compared to placebo in subjects 13-17 years of age with ADHD
- Trial name
- ADHD (NCT06215144)
- Testing
- NRCT-101SR
- Where
- 13 sites in United States
- Volunteers
- 95 people
- Sponsor
- Neurocentria, Inc.
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Nasopharyngeal Carcinoma
Phase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed/Refractory or Metastatic Solid Tumors
There is a significant unmet medical need for effective therapies for pediatric relapsed/refractory solid tumors. EGFR is highly and stably expressed in multiple pediatric solid tumor subtypes, and adult Phase I data of Becotatug…
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Nasopharyngeal Carcinoma, Lymphoepithelial Carcinoma, Rhabdomyosarcoma
- Trial name
- MRG003 (NCT07584499)
- Testing
- Becotatug Vedotin
- Where
- China
- Volunteers
- 51 people
- Sponsor
- Sun Yat-sen University
Pediatric Growth Hormone Deficiency
Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
This is an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.
- Trial name
- NCT02968004
- Testing
- MOD-4023, Somatropin
- Where
- 81 sites in United States, Argentina and 18 more
- Volunteers
- 224 people
- Sponsor
- OPKO Health, Inc.
Hypercholesterolemia
Efficacy and Safety of Colesevelam in Pediatric Patients With Genetic High Cholesterol
This study will evaluate the lipid-lowering effect and safety of colesevelam therapy administered to heterozygous familial pediatric patients 10 through 17 years of age who are on a stable dose of a pediatric-approved statin…
- Trial name
- NCT00145574
- Testing
- colesevelam HCl
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 194 people
- Sponsor
- Daiichi Sankyo
Major Depressive Disorder
Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
The primary purpose of your participation in this study is to help answer the following research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is safe and effective for the treatment of…
- Trial name
- NCT00531947
- Testing
- Selegiline Transdermal System
- Where
- 20 sites in United States
- Volunteers
- 308 people
- Sponsor
- Somerset Pharmaceuticals
Pediatric Germ Cell Tumor
Paclitaxel/Ifosfamide/Cisplatin Chemotherapy for High Risk Pediatric Germ Cell Tumor
Germ cell tumor has generally good prognosis, but high risk germ cell tumor has still very poor prognosis. There remains the need of further improvement with other chemotherapy strategy.
- Trial name
- NCT05455918
- Testing
- TIP treatment (paclitaxel/ifosfamide/cisplatin)
- Where
- South Korea
- Volunteers
- 42 people
- Sponsor
- Yonsei University
Bronchiolitis
Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis
This is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of…
- Trial name
- NCT06827249
- Testing
- Peginterferon α-2b injection, Recombinant Human Interferon α2b
- Where
- 3 sites in China
- Volunteers
- 90 people
- Sponsor
- Children's Hospital of Soochow University
Ulcerative Colitis
ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis
Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) will receive one weekly Adacolumn® apheresis treatment over 5 consecutive weeks, followed by up to 3 optional Adacolumn® apheresis treatments…
- Trial name
- NCT00781638
- Testing
- Adacolumn®
- Volunteers
- 24 people
- Sponsor
- Otsuka Frankfurt Research Institute GmbH
Anesthesia
A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised
The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during maintenance of general anesthesia.
- Trial name
- NCT01998165
- Testing
- Remifentanil
- Where
- 9 sites in Japan
- Volunteers
- 80 people
- Sponsor
- Janssen Pharmaceutical K.K.
Infant, Preterm
Evaluation of Safety and Efficacy of Remifentanil in Pediatric Population
The purpose of this study is to evaluate safety and efficacy of continuous infusion of remifentanil in preterm infant with mechanical ventilator for control of procedural pain using two different dosage of remifentanil.
- Trial name
- NCT01477892
- Testing
- low dose remifentanil
- Where
- South Korea
- Volunteers
- 14 people
- Sponsor
- Seoul National University Hospital
Hepatitis C
An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus
The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose…
- Trial name
- NCT01701063
- Testing
- Telaprevir, Peginterferon alfa-2b, Ribavirin
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 42 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Sepsis
Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis
This study evaluates the efficacy and safety of the administration of betalactam antibiotics in prolonged infusion compared to intermittent infusion in children with sepsis.
- Trial name
- NCT03019965
- Testing
- Intermittent Piperacillin/tazobactam, Continuous Piperacillin/tazobactam, Intermittent Imipenem
- Where
- 2 sites in Mexico
- Volunteers
- 426 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
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