Clinical trials: Pediatric Safety and Effectiveness
- Condition Pediatric Safety and Effectiveness
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Narcolepsy
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with…
- Trial name
- NCT00107796
- Testing
- Modafinil
- Where
- 73 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
Postoperative Pain
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal…
- Trial name
- NCT00801398
- Testing
- Oxymorphone IR
- Where
- 11 sites in United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Helicobacter Pylori, Safety
PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study
This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility.
- Conditions
- Helicobacter Pylori, Safety, Efficacy
- Trial name
- NCT05276557
- Testing
- PyloPlus Urea Breath Test System, Stool Antigen Test
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- ARJ Medical, Inc.
Bipolar Disorder
Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or Mixed).
- Trial name
- NCT01117220
- Testing
- Ziprasidone Oral Capsules
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Dental Anesthesia, Anesthesia, Local
Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients
The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.
- Conditions
- Dental Anesthesia, Anesthesia, Local, Anesthesia, Reversal
- Trial name
- NCT01474382
- Testing
- OraVerse
- Where
- 7 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Novocol Pharmaceutical of Canada, Inc.
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Mydriasis, Dilation
Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects
The objectives of this study are: To evaluate the safety of Nyxol in pediatric subjects To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically induced mydriasis in pediatric subjects The Sponsor intends…
- Trial name
- MIRA-4 (NCT05223478)
- Testing
- Phentolamine Ophthalmic Solution 0.75%, Phentolamine Ophthalmic Solution Vehicle
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Opus Genetics, Inc
Attention Deficit Hyperactivity Disorder (ADHD)
A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants
The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder…
- Trial name
- NCT01933880
- Testing
- Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH), No intervention
- Where
- 6 sites in China
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
Tinea Corporis
Pediatric Subjects With Tinea Corporis
The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm).
- Trial name
- NCT02227290
- Testing
- Naftin Cream
- Where
- 19 sites in United States, Dominican Republic and 3 more
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Merz North America, Inc.
Influenza, Human
Efficacy Study With QIVc in Pediatric Subjects
This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age.
- Trial name
- NCT03932682
- Testing
- QIVc, Comparator
- Where
- 74 sites in Bangladesh, Bulgaria and 13 more
- Volunteers
- 5,723 people, healthy volunteers welcome
- Sponsor
- Seqirus
Nasal Congestion
A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold
The study will evaluate the safety and efficacy of the study medical device plus standard of care versus standard of care in subjects between 3 and 48 months (inclusive) presenting symptoms of a common cold.
- Trial name
- NCT05365789
- Testing
- Blocked Nose Baby nasal spray, Standard of care
- Where
- Poland
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Church & Dwight Company, Inc.
Sleep Apnea, Obstructive
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with obstructive sleep…
- Trial name
- NCT00107809
- Testing
- Modafinil
- Where
- 64 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
Glycogen Storage Disease Type II-Pompe's Disease
A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa
This is a multi-stage, phase 2, open-label, multicenter, multinational, ascending dose cohort, repeated intravenous (IV) infusion study of avalglucosidase alfa in pediatric patients with Infantile-Onset Pompe Disease (IOPD) who…
- Trial name
- Mini-COMET (NCT03019406)
- Testing
- Avalglucosidase alfa (GZ402666), Alglucosidase alfa (GZ419829)
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Atopic Dermatitis
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
- Trial name
- NCT03058783
- Testing
- IDP-124 Lotion, IDP-124 Vehicle Lotion
- Where
- United States
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Upper Respiratory Tract Infections
A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population
Parents with children aged 3-11 will participate in this study. About 500 children will take part in the study. We expect about half of those children will develop symptoms of a respiratory infection.
- Trial name
- NCT00965822
- Testing
- North American ginseng
- Where
- 4 sites in Canada
- Volunteers
- 293 people, healthy volunteers welcome
- Sponsor
- Afexa Life Sciences Inc
Pupillary Dilation Effect During Cycloplegic Refraction
Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects
This is a prospective randomized study compared with active control arm.
- Trial name
- NCT06609525
- Testing
- CTO0303-A, CTO0303-B, CTO0303-C
- Where
- South Korea
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Taejoon Pharmaceutical Co., Ltd.
Atopic Dermatitis
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects (301)
Efficacy and Safety of IDP-124 Lotion for the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric and Adult Subjects
- Trial name
- NCT03002571
- Testing
- IDP-124 Lotion, IDP-124 Vehicle Lotion
- Where
- United States
- Volunteers
- 338 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
SARS-CoV Infection, Covid19
A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2
This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants.
- Trial name
- NCT04611802
- Testing
- SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
- Where
- 154 sites in United States, Mexico and 1 more
- Volunteers
- 33,000 people, healthy volunteers welcome
- Sponsor
- Novavax
Heart Murmurs, Wheezing
Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.
This study is testing a digital stethoscope called the Keikku electronic stethoscope. Doctors use stethoscopes to listen to the heart, and this new device records heart sounds using a smartphone app.
- Trial name
- KCI-1 (NCT07044128)
- Testing
- Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
- Where
- Peru
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Lapsi Health Holding B.V.
Anesthesia
Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects
The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
- Trial name
- NCT01701505
- Testing
- 400uL of Kovacaine Mist, 200uL of Kovacaine Mist, 120uL of Kovacaine Mist
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- St. Renatus, LLC