Clinical trials: Tolerability
Exocrine Pancreatic Insufficiency
Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)
Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis.
- Trial name
- NCT02598128
- Testing
- RELiZORB
- Where
- 11 sites in United States
- Volunteers
- 34 people
- Sponsor
- Alcresta Therapeutics, Inc.
Acne Vulgaris, Acne
Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris
The primary objective of this study is to compare the tolerability, safety and efficacy of NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to severe acne vulgaris.
- Trial name
- NCT01556698
- Testing
- NVN1000, Vehicle
- Where
- Dominican Republic
- Volunteers
- 70 people
- Sponsor
- Novan, Inc.
HIV Infections
Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children
Cohort I: The purpose of this study is to see how safe it is to combine 2 anti-HIV medications, efavirenz (EFZ) and nelfinavir (NFV) to treat HIV-positive children and to find an appropriate dose of EFZ to use in combination with…
- Trial name
- NCT00000893
- Testing
- Nelfinavir mesylate, Efavirenz
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 103 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Evaluation of a Rotavirus Vaccine
Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants
This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers.
- Trial name
- NCT02109484
- Testing
- P2-VP8 Subunit Vaccine 10mcg, P2-VP8 Subunit Vaccine 30 mcg, P2-VP8 Subunit Vaccine 60mcg
- Where
- South Africa
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- PATH
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Bacterial Infections.
A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.
A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
- Trial name
- NCT01946568
- Testing
- Dalbavancin
- Where
- 12 sites in United States, Estonia
- Volunteers
- 36 people
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
Pneumococcal Disease
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and…
- Trial name
- NCT07660198
- Testing
- PG4, 20-valent pneumococcal conjugate vaccine (20vPnC)
- Where
- 77 sites in United States, Finland and 2 more
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Pfizer
FSHD, FSHD1
Phase 2 Open-label Extension Study of AOC 1020 in Participants With Facioscapulohumeral Muscular Dystrophy (FSHD)
A Phase 2 Open-label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of AOC 1020 Administered Intravenously to Participants with Facioscapulohumeral Muscular Dystrophy (FSHD)
- Conditions
- FSHD, FSHD1, FSHD2, FMD
- Trial name
- FORTITUDE-OLE (NCT06547216)
- Testing
- AOC 1020
- Where
- 17 sites in United States, Canada and 1 more
- Volunteers
- 84 people
- Sponsor
- Avidity Biosciences, Inc.
COVID-19
A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children
The purpose of this clinical trial is to learn about the safety and immune responses of the study vaccine (called a bivalent BNT162b2 Omicron containing vaccine) in healthy infants and children.
- Trial name
- NCT05630352
- Testing
- Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
- Volunteers
- healthy volunteers welcome
- Sponsor
- BioNTech SE
Healthy
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
- Trial name
- NCT07160244
- Testing
- Multivalent Group B streptococcus vaccine, Infanrix hexa, Prevenar 20
- Where
- 219 sites in United States, Argentina and 13 more
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Pfizer
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
HIV Infections
A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
The purpose of this study is to examine the safety and tolerability of ZDV when given to premature infants born to HIV-positive women to prevent HIV infection.
- Trial name
- NCT00000855
- Testing
- Zidovudine
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 35 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Cough
Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold
Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex.
- Trial name
- NCT02486835
- Testing
- Cough syrup for adults and children
- Where
- 4 sites in Israel
- Volunteers
- 150 people
- Sponsor
- Clalit Health Services
Microbial Colonization
Effect of Probiotics on Infant's Fecal Microbiota Composition
Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants.
- Trial name
- BABYCARE (NCT05524649)
- Testing
- Food Supplement 1, Food Supplement 2
- Where
- 2 sites in Mexico, Spain
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- AB Biotics, SA
Influenza, Human, Acute Respiratory Infection
Efficacy and Safety of Ingavirin®, Capsules, 60 mg, in Children With Influenza and Other Acute Respiratory Viral Infections
The study is planned to evaluate the therapeutic efficacy and safety of Ingavirin®, capsules, 60 mg, in the treatment of influenza or other acute respiratory infections in children from 13 to 17 years compared with placebo.
- Conditions
- Influenza, Human, Acute Respiratory Infection, Common Cold
- Trial name
- NCT06315400
- Testing
- Ingavirin®
- Where
- 3 sites in Russia
- Volunteers
- 80 people
- Sponsor
- Valenta Pharm JSC
Human Papillomavirus Infection
A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
This study will evaluate the tolerability and immunogenicity of administration of the first dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one month prior to administration of Menactra™ and…
- Trial name
- NCT00988884
- Testing
- V503, Comparator: Menactra™ (Concomitant), Comparator: Adacel™ (Concomitant)
- Volunteers
- 1,241 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Influenza
Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
With this study the investigators will try to assess the tolerability and measurability of the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual households.
- Trial name
- NCT00833885
- Testing
- Masks, Masks & hand hygiene, Control
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- Robert Koch Institut
Malaria, Intermittent Preventive Treatment
Intermittent Preventive Treatment of Malaria in Schoolchildren
This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren.
- Trial name
- NCT00852371
- Testing
- sulfadoxine-pyrimethamine, amodiaquine + sulfadoxine-pyrimethamine, dihydroartemisinin-piperaquine
- Volunteers
- 780 people
- Sponsor
- London School of Hygiene and Tropical Medicine
Hypertension
307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects
This was a 52-week, multicenter, open-label study to determine the safety, tolerability and pharmacokinetics of TOPROL-XL (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in hypertensive pediatric subjects.
- Trial name
- NCT00255502
- Testing
- metoprolol succinate
- Where
- 31 sites in United States, Dominican Republic
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Attention Deficit Hyperactivity Disorder (ADHD)
Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.
2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children with ADHD.
- Trial name
- NCT03546400
- Testing
- methylphenidate HCl ERCT
- Sponsor
- Pfizer
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