Clinical trials: Pediatrics
Bowel Cleansing Prior to Clinical Procedures
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
The purpose of the study is to assess the efficacy, safety and tolerability of PLENVU® by measuring its bowel cleansing success rate compared to sodium picosulfate in paediatric participants aged less than 18 years who are…
- Trial name
- CLARITY (NCT07218523)
- Testing
- PLENVU®, Sodium picosulfate
- Where
- 46 sites in Belgium, Croatia and 8 more
- Volunteers
- 212 people
- Sponsor
- Norgine
Syncope, Pediatric
Pediatric Adhesion and New Dermal Approach Study
The purpose of this study is to see if the Zio® monitor device can be worn by children for up to 14-days and to determine if the skin preparation process will provide good adherence to the skin and clear signal quality.
- Conditions
- Syncope, Pediatric, Congenital Athymia, Congenital Heart Disease
- Trial name
- PANDA (NCT07118124)
- Testing
- Zio monitor
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- iRhythm Technologies, Inc.
Diabetes Mellitus, Type 2
Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus
The purpose of this study is to determine the pharmacokinetic and safety profile of alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.
- Trial name
- NCT00957268
- Testing
- Alogliptin
- Where
- 7 sites in United States
- Volunteers
- 46 people
- Sponsor
- Takeda
Hereditary Angioedema (HAE)
Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema
The primary objective of this study is: assess the safety and tolerability of ecallantide in paediatric patients for acute attacks of HAE The secondary objectives are: evaluate the pharmacokinetic profile of ecallantide in…
- Trial name
- NCT01253382
- Testing
- ecallantide
- Sponsor
- Shire
Pneumococcal Infections
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations…
- Trial name
- NCT00452790
- Testing
- 13-valent Pneumococcal Conjugate Vaccine, 7 valent pneumococcal conjugate vaccine
- Where
- 12 sites in India
- Volunteers
- 708 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Pediculosis
Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation
A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in pediatric subjects 6 months to 4 years of age with an active head lice infestation.
- Trial name
- NCT01660321
- Testing
- spinosad
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- ParaPRO LLC
B Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia
CD19 /22 CAR T Cells (AUTO3) for the Treatment of B Cell Acute Lymphoblastic Leukemia (ALL)
The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment targeting CD19 and CD22 in paediatric or young adult patients with relapsed or refractory B cell acute lymphoblastic leukaemia.
- Conditions
- B Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Refractory Childhood Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia
- Trial name
- AMELIA (NCT03289455)
- Testing
- AUTO3 (CD19/22 CAR T cells
- Where
- 3 sites in United Kingdom
- Volunteers
- 23 people
- Sponsor
- Autolus Limited
Growth Disorders
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Mexico
This is a Mexican, Multicentre, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of…
- Trial name
- ECOS MEX (NCT01555528)
- Testing
- easypod™
- Where
- Mexico
- Volunteers
- 193 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Gastroesophageal Reflux Disease (GERD)
A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive
The purpose of the study is to evaluate the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time), pharmacodynamics (how the study medication affects…
- Trial name
- NCT00747526
- Testing
- Rabeprazole sodium 5 mg, Rabeprazole sodium 10 mg
- Where
- 20 sites in United States, Belgium and 3 more
- Volunteers
- 51 people
- Sponsor
- Janssen Research & Development, LLC
Respiratory Failure
Trilogy Comparison Study - Pediatrics
The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device).
- Trial name
- NCT00810459
- Testing
- Trilogy Ventilator, Standard of Care
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- Philips Respironics
Growth Disorders
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Austria
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 hospitals in Austria…
- Trial name
- ECOS AUT (NCT01296425)
- Testing
- Easypod™
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Solid Tumours
Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors
The study design was an open-label Phase II pediatric clinical study. The purpose of Study X2203 was to identify any efficacy signal in subjects with the disease subtypes under study, when treated with pazopanib monotherapy.
- Trial name
- NCT01956669
- Testing
- Pazopanib
- Where
- 31 sites in United States, Canada and 5 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
HIV Infections
Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children
The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.
- Trial name
- NCT00528957
- Testing
- Tenofovir DF, Zidovudine, Stavudine
- Where
- 9 sites in United States, Panama and 1 more
- Volunteers
- 97 people
- Sponsor
- Gilead Sciences
Constipation
Single Dose Pharmacokinetics of Prucalopride in Paediatric Subjects, With Functional Faecal Retention
The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal retention.
- Trial name
- NCT01674166
- Testing
- prucalopride
- Volunteers
- 38 people
- Sponsor
- Movetis
Constipation - Functional
Lubiprostone in Children With Functional Constipation
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
- Trial name
- NCT02042183
- Testing
- Lubiprostone
- Where
- 117 sites in United States, Belgium and 5 more
- Volunteers
- 606 people
- Sponsor
- Sucampo Pharma Americas, LLC
HIV Infections
Safety and Efficacy of Tenofovir DF in HIV-1 Infected Adolescents Failing Their Current Antiretroviral Therapy
The purpose of this study is to assess the safety and efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) plus a genotype-guided optimized background regimen (OBR) compared to placebo plus OBR in the treatment of human…
- Trial name
- NCT00352053
- Testing
- Tenofovir DF
- Where
- 18 sites in Brazil, Panama
- Volunteers
- 87 people
- Sponsor
- Gilead Sciences
Controlled Asthma
Modelling of the Upper Airway in Children With Controlled Asthma
Asthma in children is recognized as a disease area with a high medical need. As the investigators move into this field it is necessary to improve the investigators knowledge of upper airway anatomical structure in paediatric…
- Trial name
- NCT01594151
- Testing
- Cone Beam Computed Tomography
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- FLUIDDA nv
Candidemia
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
Prospective, open label study to assess the pharmacokinetics, safety \& efficacy of anidulafungin when used to treat children (aged 1 month - <18 years) with invasive candidiasis, including candidemia (ICC).
- Trial name
- NCT00761267
- Testing
- Anidulafungin, Fluconazole
- Where
- 45 sites in United States, Brazil and 8 more
- Volunteers
- 70 people
- Sponsor
- Pfizer
Epilepsy; Paediatric Partial Onset Seizures
Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study)
The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.
- Trial name
- NCT00566254
- Testing
- Zonisamide
- Where
- 43 sites in Belgium, Estonia and 7 more
- Volunteers
- 207 people
- Sponsor
- Eisai Inc.
Human Immunodeficiency Virus
An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children
The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents.
- Trial name
- NCT00791700
- Testing
- Maraviroc
- Where
- 41 sites in United States, Brazil and 7 more
- Volunteers
- 103 people
- Sponsor
- ViiV Healthcare