Clinical trials: Pediatric Safety and Effectiveness
Pulmonary Arterial Hypertension
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) <12 years of age.
- Trial name
- FUTURE 3 (NCT01223352)
- Testing
- bosentan
- Volunteers
- 64 people
- Sponsor
- Actelion
Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency
Auditory Brainstem Implantation in Young Children
To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children without the diagnosis of neurofibromatosis…
- Conditions
- Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency, Cochlear Aplasia, Post-meningitis Cochlear Ossification
- Trial name
- NCT01904448
- Testing
- Auditory Brainstem Implantation in Children
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of North Carolina, Chapel Hill
Irritable Bowel Syndrome Characterized by Constipation
Food Supplement Physiomanna® Baby in Pediatric Patients
The primary objective is to assess the efficacy and safety of the Food Supplement Physiomanna® Baby in pediatric patients with a history of functional constipation The secondary objective of the trial is to evaluate the adherence…
- Trial name
- NCT02732743
- Testing
- Physiomanna® Baby
- Where
- Romania
- Volunteers
- 45 people
- Sponsor
- Iuppa Industriale Srl
Epilepsy, Partial
A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is…
- Trial name
- NCT00150709
- Testing
- Levetiracetam
- Volunteers
- 223 people
- Sponsor
- UCB Pharma
Crohn's Disease
Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels.
- Trial name
- U-EMPOWER (NCT06332534)
- Testing
- Upadacitinib
- Where
- 85 sites in United States, Australia and 16 more
- Volunteers
- 111 people
- Sponsor
- AbbVie
Rhabdomyosarcoma, Recurrent, Refractory
Evaluation of the Efficacy and Safety of Pazopanib in Combination with TGI/CIV for Recurrent or Refractory Rhabdomyosarcoma in Children or Adolescents
To evaluate the efficacy and safety of pazopanib combined with TGI/CIV chemotherapy in children and adolescents with recurrent or refractory rhabdomyosarcoma.
- Trial name
- NCT06816771
- Testing
- pazopanib, TGI chemotherapy, CIV chemotherapy
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Shandong Cancer Hospital and Institute
Generalized Tonic Clonic Seizures
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo.
- Trial name
- NCT01747915
- Testing
- Pregabalin Dose Level 1, Pregabalin Dose Level 2
- Where
- 127 sites in United States, Austria and 24 more
- Volunteers
- 219 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Postoperative Pain
A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block
The purpose of this study is to retrospectively compare perioperative pain relief and safety in pediatric patients who have received a femoral nerve block with varying concentrations of local anesthetic.
- Trial name
- NCT02501135
- Testing
- Femoral nerve block with ropivacaine or bupivacaine
- Volunteers
- 281 people
- Sponsor
- Giorgio Veneziano
Pediatric Intestinal Failure
KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
A multi-site, randomized, 2-arm open-label trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (standard of care) in preventing central venous catheter occlusions in children…
- Trial name
- NCT05879835
- Testing
- KiteLock 4% Sterile Catheter Lock Solution, Heparin Lock Solution
- Where
- 8 sites in United States
- Volunteers
- 124 people
- Sponsor
- SterileCare Inc.
Epilepsy, Partial Seizures
A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter study to evaluate the safety and efficacy of two dose levels of pregabalin administered in equally divided daily doses, in either…
- Trial name
- PERIWINKLE (NCT01389596)
- Testing
- Pregabalin add-on therapy
- Where
- 86 sites in United States, Belgium and 16 more
- Volunteers
- 295 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Ocular Redness, Eye Irritation
An Investigation of FID 123320 for the Reduction of Ocular Redness in Pediatric and Adult Populations
The purpose of this study is to assess the safety and efficacy of FID 123320 Ophthalmic Solution compared to Vehicle for relieving redness of the eye due to minor eye irritations in pediatric and adult populations.
- Trial name
- NCT06538662
- Testing
- FID 123320 Ophthalmic Solution, Vehicle
- Where
- 10 sites in United States
- Volunteers
- 283 people
- Sponsor
- Alcon Research
Growth Hormone Deficiency, Pediatric, Endocrine System Diseases
A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency
A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (GHD) will be included.
- Conditions
- Growth Hormone Deficiency, Pediatric, Endocrine System Diseases, Hormone Deficiency, Pituitary Diseases
- Trial name
- NCT03305016
- Testing
- TransCon hGH
- Where
- 24 sites in United States, Australia and 2 more
- Volunteers
- 146 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Duchenne Muscular Dystrophy
Phase I/II Study of SRP-4053 in DMD Patients
This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 53 skipping.
- Trial name
- NCT02310906
- Testing
- SRP-4053
- Where
- 5 sites in United States, France and 2 more
- Volunteers
- 39 people
- Sponsor
- Sarepta Therapeutics, Inc.
Overactive Detrusor, Neurogenic Bladder
Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition.
- Trial name
- NCT01192568
- Testing
- Oxybutynin
- Where
- 10 sites in United States
- Volunteers
- 52 people
- Sponsor
- AbbVie
Vitamin A Deficiency, Pediatric
Efficacy and Safety of Vitamin A Treatment for Children With Sepsis
The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.
- Conditions
- Vitamin A Deficiency, Pediatric, Sepsis
- Trial name
- NCT04127968
- Testing
- Vitamin A, Oil
- Volunteers
- 450 people
- Sponsor
- West China Hospital
Cerebral Palsy, Muscle Spasticity
Dysport® Pediatric Lower Limb Spasticity Follow-on Study
The purpose of this research study was to determine the long term safety and efficacy of repeated treatments with Dysport® used in the treatment of lower limb spasticity in children with dynamic equinus foot deformity due to…
- Conditions
- Cerebral Palsy, Muscle Spasticity, Children
- Trial name
- NCT01251380
- Testing
- Botulinum toxin type A
- Where
- 27 sites in United States, Chile and 4 more
- Volunteers
- 216 people
- Sponsor
- Ipsen
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin
A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)
This is a Phase 1/2, open-label, single arm, multicohort study to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL.
- Trial name
- NCT03743246
- Testing
- JCAR017, Lymphodepleting, Fludarabine
- Where
- 19 sites in United States, France and 4 more
- Volunteers
- 21 people
- Sponsor
- Celgene
Melanoma
A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma
The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated…
- Trial name
- NCT06163170
- Testing
- Nivolumab +/- ipilimumab, Nivolumab
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Bristol-Myers Squibb
Plaque Psoriasis
A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.
- Trial name
- NCT05565560
- Testing
- Apremilast
- Where
- 29 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Amgen
Pediatric Solid Tumor, Pediatric Lymphoma
Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas
The study evaluates CLR 131 in children, adolescents, and young adults with relapsed or refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there are no standard treatment…
- Conditions
- Pediatric Solid Tumor, Pediatric Lymphoma, Pediatric Brain Tumor, DIPG
- Trial name
- CLOVER-2 (NCT03478462)
- Testing
- CLR 131
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 30 people
- Sponsor
- Cellectar Biosciences, Inc.
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