Clinical trials: Pediatric Safety and Effectiveness
Down Syndrome, Cognitive Dysfunction
Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10
The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of cognitive dysfunction shown by children with Down syndrome, aged 6 to 10 years.
- Trial name
- NCT00754013
- Testing
- Aricept (Donepezil hydrochloride)
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Eisai Inc.
Attention-Deficit/Hyperactivity Disorder
Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)
Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients
- Trial name
- NCT02736656
- Testing
- SPN-812
- Where
- 16 sites in United States
- Volunteers
- 1,400 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Skin Diseases, Infectious
Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to 17 years, inclusive, with complicated skin…
- Trial name
- NCT00711802
- Testing
- Daptomycin, Standard of Care (SOC)
- Where
- 30 sites in United States, India and 1 more
- Volunteers
- 396 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Cataracts, Inflammation
Difluprednate Pediatric Study for the Treatment of Inflammation Post-Cataract Surgery
The primary objective of this study was to compare the safety and efficacy of Durezol™ compared to Pred Forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.
- Trial name
- NCT01124045
- Testing
- Difluprednate ophthalmic emulsion, 0.05%, Prednisolone acetate ophthalmic suspension, 1.0%
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Alcon Research
Immune Tolerance, Immunosuppression
Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation
The goal of this clinical trial is to learn about the efficacy and safety of immunosuppressive withdrawal in pediatric liver transplant recipients.
- Conditions
- Immune Tolerance, Immunosuppression, Liver Transplant; Complications
- Trial name
- NCT06147375
- Testing
- Tacrolimus or Cyclosporine A
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Wei Gao
Brain Tumor
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
- Trial name
- NCT04085887
- Testing
- Panitumumab-IRDye800, Pinpoint-IR9000 endoscopic/handheld device, Explorer Air camera
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stanford University
Anxiety State, Perioperative/Postoperative Complications
a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
This research study to evaluate the relative efficacy of Dexmedetomidine, Midazolam, and compare them to the current KFSH\&RC standard of care. Compare the safety and the frequency of adverse effects of treatment arms.
- Trial name
- NCT04356638
- Testing
- Midazolam, Dexmedetomidine
- Where
- Saudi Arabia
- Volunteers
- 80 people
- Sponsor
- King Faisal Specialist Hospital & Research Center
Peanut Allergy
Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy
The primary objective of the study is to assess the tolerability of peanut protein in pediatric patients (6-17 years old) treated with dupilumab monotherapy, in which tolerability is defined as the proportion of patients who…
- Trial name
- NCT03793608
- Testing
- Dupilumab
- Where
- 9 sites in United States, Canada
- Volunteers
- 25 people
- Sponsor
- Regeneron Pharmaceuticals
Inflammatory Bowel Diseases, Crohn's Disease
Thalidomide in Pediatric Inflammatory Bowel Diseases.
Several open-label studies reported thalidomide efficacy in inducing clinical remission and steroid tapering in refractory Inflammatory Bowel diseases (IBD), both in adults and in children.
- Conditions
- Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis
- Trial name
- TALIBDP (NCT00720538)
- Testing
- Thalidomide
- Where
- 7 sites in Italy
- Volunteers
- 84 people
- Sponsor
- IRCCS Burlo Garofolo
Type 1 Diabetes
Artificial Pancreas in Pediatric Patients (PEDarPAN)
The purpose of this study is to determine safety, feasibility and efficacy (with respect to sensor- augmented pump therapy) of an Artificial Pancreas (AP) prototype in day and night closed-loop control in children and adolescents…
- Trial name
- PEDarPAN (NCT02620878)
- Testing
- artificial pancreas, sensor augmented pump
- Where
- Italy
- Volunteers
- 48 people
- Sponsor
- University of Padova
Plaque Psoriasis
Clinical Study of Stage IV Psoriasis in Children With Geleli
This study is a multicenter, prospective, observational phase IV clinical study. A total of 80 children and adolescents with severe plaque psoriasis were included in the study.
- Trial name
- NCT05803187
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Bio-Thera Solutions
Nasal Congestion and Inflammations, Rhinitis
Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis
This is a multicenter clinical trial, phase III, non-inferiority, controlled by active medicine, open, randomized, enroll 538 children, 2 to 12 years old, with acute inflammation upper airway, characterized by nasal congestion…
- Trial name
- NCT01393548
- Testing
- brompheniramine + phenylephrine, Brompheniramine + pseudoephedrine
- Where
- Brazil
- Volunteers
- 879 people
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
Atopic Dermatitis
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)
Primary Objective: To evaluate safety (4 weeks) Secondary Objectives: To evaluate the long-term safety (12 weeks) To evaluate the efficacy To characterize the pharmacokinetic profile
- Trial name
- NCT01244230
- Testing
- fexofenadine/Allegra (M016455)
- Where
- 13 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Sanofi
Neutropenia, Fever
MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)
This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter…
- Trial name
- NCT00082537
- Testing
- caspofungin acetate, Comparator: AmBisome
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Pompe Disease (Late-onset)
ZIP Study-OL Study of Safety, PK, Efficacy, PD, Immunogenicity of ATB200/AT2221 in Pediatrics Aged 0 to < 18 y.o. w/LOPD
This is a Phase 3, open-label, multicenter study to evaluate the safety, PK, efficacy, PD, and immunogenicity of Cipaglucosidase Alfa/Miglustat treatment in enzyme replacement therapy (ERT)-experienced and ERT-naïve pediatric…
- Trial name
- NCT03911505
- Testing
- Cipaglucosidase Alfa, Miglustat
- Where
- 17 sites in United States, Australia and 4 more
- Volunteers
- 21 people
- Sponsor
- Amicus Therapeutics
Anesthesia, Dental
Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures
This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11 years of age.
- Trial name
- NCT00309322
- Testing
- Phentolamine Mesylate (NV-101)
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Novalar Pharmaceuticals, Inc.
Child
Femoral Central Venous Access Comparison of 2 Methods
The purpose of this study is to compare the effectiveness and safety of the installation of femoral central venous catheter (CVC) ultrasound-guided real-time 2D versus the landmark method
- Trial name
- NCT02318940
- Testing
- central venous catheter
- Where
- 2 sites in Chile
- Volunteers
- 99 people
- Sponsor
- University of Chile
Immune Thrombocytopenia
Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months
A Phase 3b Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months
- Trial name
- NCT04516967
- Testing
- Avatrombopag
- Where
- 62 sites in United States, France and 7 more
- Volunteers
- 75 people
- Sponsor
- Sobi, Inc.
Fragile X Syndrome
A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome
This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with fragile X syndrome.
- Trial name
- NCT01750957
- Testing
- RO4917523
- Where
- 20 sites in United States
- Volunteers
- 47 people
- Sponsor
- Hoffmann-La Roche
Fever, Neutropenia
Low-risk Fever and Neutropenia in Children With Cancer: Safety and Efficacy of Oral Antibiotics in an Outpatient Setting
The purpose of this study is to determine whether, in children with cancer presenting with fever in severe chemotherapy-induced neutropenia at low risk for medical complications, oral antibiotics in an outpatient setting after an…
- Conditions
- Fever, Neutropenia, Cancer
- Trial name
- NCT00107081
- Testing
- ciprofloxacin and amoxicillin, Outpatient management, i.v. antibiotics
- Where
- 12 sites in Germany, Netherlands and 1 more
- Volunteers
- 70 people
- Sponsor
- Swiss Pediatric Oncology Group
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