Clinical trials: Geriatric Assessment
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Cystic Fibrosis
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109…
- Trial name
- NCT02544451
- Testing
- LUM/IVA
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 246 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Attention Deficit Disorder With Hyperactivity
Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.
- Trial name
- NCT00150592
- Testing
- SPD503 (Guanfacine HCl)
- Volunteers
- 182 people
- Sponsor
- Shire
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
- Trial name
- NCT00779779
- Testing
- Rotarix™
- Where
- Sri Lanka
- Volunteers
- 522 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza, Human
Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines
This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5 mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza and non-adjuvanted influenza control…
- Trial name
- NCT00644059
- Testing
- Adjuvanted trivalent inactivated subunit influenza vaccine, Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine, Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine
- Where
- 101 sites in Finland, Germany and 1 more
- Volunteers
- 4,902 people, healthy volunteers welcome
- Sponsor
- Novartis
Influenza Caused by the Novel Influenza A (H1N1) Virus
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.
- Trial name
- NCT00940108
- Testing
- CSL425
- Where
- 5 sites in Australia
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Seqirus
Skin Infections, Bacterial
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).
- Trial name
- NCT00555061
- Testing
- Retapamulin Ointment, 1%
- Where
- 25 sites in United States, Argentina and 7 more
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Immunogenicity, Vaccine
A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHINESE CHILDREN AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS
This is a PAC study after PCV13 launch in China. Based on recommendation from China Agency, Pfizer was required to conduct a descriptive immunogenicity study to measure the antibody levels at the time of disease onset.
- Trial name
- NCT05372575
- Testing
- PCV13 PAC study
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Pfizer
Childhood Obesity
Painted Playgrounds: Aim 2: Assessments
The Painted Playgrounds Aim 2 (Assessment) project will examine the effects of a stenciling intervention aimed at increasing physical activity and improving fundamental motor skill functioning of preschool aged children.
- Trial name
- NCT03885518
- Testing
- Playground Stencils
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Cystic Fibrosis
A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation
Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance…
- Trial name
- NCT02516410
- Testing
- VX-661 plus ivacaftor combination, Ivacaftor
- Where
- 41 sites in United States, Australia and 5 more
- Volunteers
- 168 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Gastroesophageal Reflux Disease
Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents
The purpose of this study was to assess the safety and effectiveness of once daily oral administration of dexlansoprazole delayed-release capsules in adolescent participants with symptomatic non-erosive gastroesophageal reflux…
- Trial name
- NCT01642602
- Testing
- Dexlansoprazole
- Where
- 64 sites in United States, Belgium and 6 more
- Volunteers
- 104 people
- Sponsor
- Takeda
Constipation - Functional
Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation
A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years diagnosed with functional constipation.
- Trial name
- NCT02766777
- Testing
- Lubiprostone
- Where
- 13 sites in United States
- Volunteers
- 87 people
- Sponsor
- Sucampo Pharma Americas, LLC
Adverse Event Following Immunisation
A Study to Evaluate the Safety and Immunogenicity of Oral Polio Vaccine Type 2 in Infants and Children
Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol.
- Trial name
- M2-ABMG (NCT02521974)
- Testing
- SABIN monovalent OPV2
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Fidec Corporation
Postoperative Pain, Acute Pain
Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain
To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose.
- Trial name
- NCT01729728
- Testing
- Tapentadol
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Grünenthal GmbH
PAH
Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years
This was a multi-center, open-label, safety, tolerability and pharmacokinetic study of oral treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who were (1) transitioning from parenteral Remodulin therapy; (2)…
- Trial name
- NCT02276872
- Testing
- oral treprostinil
- Where
- 9 sites in United States
- Volunteers
- 32 people
- Sponsor
- United Therapeutics
Type 2 Diabetes Mellitus
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM) following oral administration of Saxagliptin and…
- Trial name
- NCT01525225
- Testing
- Metformin immediate release (IR), Saxagliptin, Metformin IR
- Where
- 7 sites in United States
- Volunteers
- 4 people
- Sponsor
- AstraZeneca
Acute Respiratory Infection
Efficacy and Safety of Polyoxidonium, Nasal and Sublingual Spray, 6 mg/ml in Children Aged 1-12 Years With ARI
The purpose of this study is is to demonstrate superiority of Polyoxidonium, nasal and sublingual spray, 6 mg/ml over placebo in children aged from 1 to 12 years with acute respiratory viral infections.
- Trial name
- NCT03840135
- Testing
- Polyoxidonium 6 mg/ml
- Where
- 11 sites in Russia
- Volunteers
- 172 people
- Sponsor
- NPO Petrovax
Cystic Fibrosis
Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation
The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR)…
- Trial name
- STRIVE (NCT00909532)
- Testing
- Ivacaftor
- Where
- 65 sites in United States, Australia and 6 more
- Volunteers
- 167 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Herpes Simplex
Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12).
- Trial name
- NCT00224484
- Testing
- GSK208141, Havrix (investigational formulation)
- Where
- 151 sites in United States, Australia and 16 more
- Volunteers
- 5,960 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Clostridioides Difficile Infection
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.
- Trial name
- Ri-CoDIFy 3 (NCT04802837)
- Testing
- Ridinilazole, Vancomycin
- Where
- 18 sites in United States
- Volunteers
- 2 people
- Sponsor
- Summit Therapeutics