Clinical trials: Safety
Dermatitis, Dermatitis, Atopic
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis.
- Conditions
- Dermatitis, Dermatitis, Atopic, Eczema, Skin Diseases
- Trial name
- NCT03627767
- Testing
- PF-04965842 100 mg, PF-04965842 200 mg
- Where
- 235 sites in United States, Argentina and 19 more
- Volunteers
- 1,235 people
- Sponsor
- Pfizer
Asthma
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of…
- Trial name
- NCT01147744
- Testing
- Fluticasone Propionate 100mcg via ACCUHALER/DISKUS, GSK2190915 100mg, GSK2190915 10mg
- Where
- 84 sites in United States, Bulgaria and 4 more
- Volunteers
- 700 people
- Sponsor
- GlaxoSmithKline
Papillomavirus Infections
Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)
The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India.
- Trial name
- NCT00380367
- Testing
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Meningococcal Disease
Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously…
- Trial name
- NCT01992536
- Testing
- MenABCWY+OMV, MenABCWY+¼OMV
- Where
- 13 sites in United States, Poland
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Infections, Meningococcal
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the…
- Trial name
- NCT02212457
- Testing
- Bexsero, Havrix, MenABCWY
- Where
- 32 sites in United States, Finland and 1 more
- Volunteers
- 1,063 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Distress Syndrome in Premature Infant
A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.
- Trial name
- NCT03969992
- Testing
- AeroFact, nCPAP
- Where
- 41 sites in United States, Canada
- Volunteers
- 261 people
- Sponsor
- Aerogen Pharma Limited
Vaccines, Pneumococcal
Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations…
- Trial name
- NCT00474539
- Testing
- 13-valent pneumococcal conjugate vaccine, 7-valent pneumococcal conjugate vaccine
- Where
- 27 sites in Spain
- Volunteers
- 449 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Alzheimer Disease
Safety and Efficacy of TRx0237 in Subjects With Alzheimer's Disease Followed by Open-Label Treatment
The purpose of this study is to determine the safety and efficacy of TRx0237 16 mg/day and 8 mg/day in the treatment of subjects with Alzheimer's Disease compared to placebo.
- Trial name
- NCT03446001
- Testing
- TRx0237 16 mg/day, Control, TRx0237 8 mg/day
- Where
- 103 sites in United States, Belgium and 6 more
- Volunteers
- 598 people
- Sponsor
- TauRx Therapeutics Ltd
Psoriasis
Etanercept (Enbrel®) in Psoriasis - Pediatrics
This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis.
- Trial name
- NCT00078819
- Testing
- Etanercept
- Volunteers
- 211 people
- Sponsor
- Amgen
Short Bowel Syndrome
Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition
Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on…
- Trial name
- NCT02682381
- Testing
- Teduglutide 0.05mg/kg, Teduglutide 0.025 mg/kg, Standard of Care
- Where
- 27 sites in United States, Belgium and 5 more
- Volunteers
- 59 people
- Sponsor
- Shire
Pneumococcal Disease
Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers
This study evaluated the change in nasopharyngeal carriage (NPC) of Streptococcus pneumoniae (SPn), hypothesizing that it would be reduced post-vaccination with Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide…
- Trial name
- NCT02146365
- Where
- Kenya
- Volunteers
- 297 people, healthy volunteers welcome
- Sponsor
- PATH
Neoplasms
Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
This trial will evaluate safety and efficacy of human engineered T-cell therapies, in participants with advanced tumors. This trial is a sub study of the Master study NCT03967223.
- Trial name
- NCT05993299
- Testing
- Letetresgene autoleucel, Cyclophosphamide, Fludarabine
- Where
- 38 sites in United States, Canada and 5 more
- Volunteers
- 7 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Ulcerative Colitis
Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.
- Trial name
- PACE (NCT02093663)
- Testing
- MMX Mesalamine/Mesalazine (Low Dose), MMX Mesalamine/Mesalazine (High Dose)
- Where
- 33 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Shire
CLN3-related Disorders, Non-CLN3 Related Low Vision
Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision
Background: CLN3 involves vision loss observed around the preschool years, with eventual progression to blindness within 1-3 years.
- Trial name
- NCT04974307
- Testing
- OrCam MyEye 2
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Fibrodysplasia Ossificans Progressiva
In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation (heterotopic ossification…
- Trial name
- NCT02521792
- Testing
- Palovarotene
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Pacemaker Indication
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and…
- Trial name
- NCT00916344
- Testing
- EVIA Pacemaker
- Where
- France
- Volunteers
- 175 people
- Sponsor
- Biotronik SE & Co. KG
ADHD
Evaluate the Safety and Efficacy of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD
To evaluate the long-term, safety of Methylphenidate Transdermal System (MTS) in aged 13-17 years diagnosed withADHD
- Trial name
- NCT00501293
- Testing
- Methylphenidate Transdermal System
- Where
- 32 sites in United States
- Volunteers
- 163 people
- Sponsor
- Noven Therapeutics
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age
A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product…
- Trial name
- NCT01100606
- Testing
- EUR-1008 (APT-1008)
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Forest Laboratories
Rotavirus
Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when administered as a two-dose primary…
- Trial name
- NCT02141204
- Testing
- HRV Liquid, HRV Lyophilized
- Where
- 8 sites in India
- Volunteers
- 451 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Otitis Media, Infections, Respiratory Tract
Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India
Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses.
- Conditions
- Otitis Media, Infections, Respiratory Tract, Respiratory Tract Infections
- Trial name
- NCT04600752
- Testing
- Augmentin (ES)-600
- Where
- 13 sites in India
- Volunteers
- 310 people
- Sponsor
- GlaxoSmithKline
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