Clinical trials: Strength
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
Allergic Rhinitis Due to House Dust Mite, Allergic Conjunctivitis Due to Dermatophagoides Farinae
Noninterventional Study on Tolerability and Safety of One Strength Updosing With Novo-Helisen Depot House Dust Mites
The goal of this non-interventional study is to investigate the safety and tolerability of a new simplified up-dosing schedule for Novo-Helisen Depot.
- Conditions
- Allergic Rhinitis Due to House Dust Mite, Allergic Conjunctivitis Due to Dermatophagoides Farinae, Allergic Conjunctivitis Due to Dermatophagoides Pteronyssinus, Allergic Asthma Due to Dermatophagoides Farinae
- Trial name
- NOVUS-UP (NCT07096440)
- Volunteers
- 105 people
- Sponsor
- Allergopharma GmbH & Co. KG
Severe Hemophilia A
Pharmacokinetics of rFVIIIFc at Two Vial Strengths
The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A.
- Trial name
- NCT02083965
- Testing
- rFVIIIFc
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 19 people
- Sponsor
- Bioverativ Therapeutics Inc.
Type 2 Spinal Muscular Atrophy
Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)
This was a Phase III multi-center, single dose (1.2 x 10^14 vector genomes), randomized, sham controlled, double-blind study that investigates the efficacy, safety and tolerability of OAV101B in treatment naive, sitting and never…
- Trial name
- STEER (NCT05089656)
- Testing
- OAV101
- Where
- 42 sites in United States, Brazil and 11 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Port Wine Stains
Rapamycin Dose-Ranging Efficacy Study in Port Wine Stains
The goal of this clinical trial is to learn if the use of rapamycin cream can be used as a treatment together with pulsed dyed laser in treating port wine stain birthmarks.
- Trial name
- NCT07436611
- Testing
- Rapamycin cream, Pulsed dyed laser
- Where
- 2 sites in United States, Spain
- Volunteers
- 30 people
- Sponsor
- AFT Pharmaceuticals, Ltd.
Pediculus Humanus Capitis (Head Lice)
Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation
This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo.
- Trial name
- NCT00857948
- Testing
- ivermectin treatment conditioner
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Topaz Pharmaceuticals Inc
Spinal Muscular Atrophy (SMA)
Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials
This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial.
- Trial name
- SPECTRUM (NCT05335876)
- Testing
- onasemnogene abeparvovec
- Where
- 32 sites in United States, Australia and 17 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Infant Development
Effects of an Infant Formula on Growth, Safety and Efficacy for Healthy Term Infants
The purpose of this study is to evaluate that a Cow's Milk Based Infant Formula A2 Containing Both OPO and CPP for healthy term infants supports age-appropriate growth.
- Trial name
- NCT04749290
- Testing
- Study Formula
- Where
- 2 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Bunge Loders Croklaan
Asthma
Evaluating the Efficacy and Safety of Fluticasone Furoate in the Treatment of Asthma in Adults and Adolescents
A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high…
- Trial name
- NCT01431950
- Testing
- fluticasone furoate, albuterol/salbutamol
- Where
- 40 sites in United States, Argentina and 4 more
- Volunteers
- 238 people
- Sponsor
- GlaxoSmithKline
Muscular Atrophy, Spinal
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA) (OFELIA)
This was a phase IV Open-label, single-arm, single-dose, multicenter study, to evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with SMA with bi-allelic mutations in…
- Trial name
- OFELIA (NCT05073133)
- Testing
- OAV101
- Where
- 5 sites in Argentina, Brazil
- Volunteers
- 16 people
- Sponsor
- Novartis Pharmaceuticals
Osteoporosis
GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients
The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study.
- Trial name
- NCT05966974
- Where
- Belgium
- Volunteers
- 44 people
- Sponsor
- AgNovos Healthcare, LLC
Asthma
Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry
A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily in the treatment of asthma in…
- Trial name
- NCT01498653
- Testing
- GW685698/GW642444, CCI18781
- Where
- 24 sites in China, Philippines and 1 more
- Volunteers
- 313 people
- Sponsor
- GlaxoSmithKline
Osteoporosis
CONFIRM - Study of AGN1 LOEP in Patients With Osteoporosis
The study will evaluate the immediate procedure and post-procedure profile of the AGN1 Femoral LOEP™ Kit. All subjects will receive the treatment and be evaluated for any adverse or serious adverse events that could occur during…
- Trial name
- NCT02916953
- Testing
- AGN1 Femoral Local Osteo-Enhancement Procedure
- Where
- 5 sites in Belgium, Netherlands
- Volunteers
- 60 people
- Sponsor
- AgNovos Healthcare, LLC
Mucopolysaccharidosis IVA, Morquio A Syndrome
Safety and Exercise Study of Two Doses of BMN 110 for Morquio A Syndrome
The primary objective of this study was to evaluate the safety of a 2.0 mg/kg/week and a 4.0 mg/kg/week of BMN 110 in patients with Morquio A syndrome for up to 196 weeks.
- Conditions
- Mucopolysaccharidosis IVA, Morquio A Syndrome, MPS IVA
- Trial name
- NCT01609062
- Testing
- BMN 110
- Where
- 11 sites in United States, Canada and 2 more
- Volunteers
- 25 people
- Sponsor
- BioMarin Pharmaceutical
Asthma
Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry.
A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily for 12 weeks in the…
- Trial name
- NCT01498679
- Testing
- GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)
- Where
- 28 sites in China, Philippines and 1 more
- Volunteers
- 311 people
- Sponsor
- GlaxoSmithKline
Osteoporosis
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study.
- Trial name
- NCT05202678
- Testing
- AGN1 LOEP
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- AgNovos Healthcare, LLC
Severe Hemophilia A
Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale
The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of 2000 L (2K) to the PK of rFVIIIFc manufactured at…
- Trial name
- Elevate (NCT02502149)
- Testing
- rFVIIIFc
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 24 people
- Sponsor
- Bioverativ Therapeutics Inc.
Spinal Muscular Atrophy
Phase IIIb, Open-label, Multi-center Study to Evaluate Safety, Tolerability and Efficacy of OAV101 Administered Intrathecally to Participants With SMA Who Discontinued Treatment With Nusinersen or Risdiplam
This was a Phase IIIb open-label, single arm, multi-center study to evaluate the safety, tolerability and efficacy of OAV101B in participants with SMA aged 2 to <18 years after the discontinuation of treatment with nusinersen or…
- Trial name
- STRENGTH (NCT05386680)
- Testing
- OAV101
- Where
- 13 sites in United States, Australia and 7 more
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Infections, Bacterial
A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS
The purpose of this study is to evaluate the pharmacokinetics, safety or tolerability through treatment emergent adverse event (TEAE) and to explore primary and secondary clinical response of treatment with Augmentin ES in…
- Trial name
- NCT05340257
- Testing
- Augmentin ES
- Where
- 2 sites in Brazil
- Sponsor
- GlaxoSmithKline
Duchenne Muscular Dystrophy
Safety and Efficacy of P-188 NF in DMD Patients
This is an open-label study to evaluate the safety, tolerability and efficacy of daily, subcutaneous dosing with P-188 NF (Carmeseal-MD™) in non-ambulatory boys with Duchenne Muscular Dystrophy (DMD).
- Trial name
- NCT03558958
- Testing
- P-188 NF
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Phrixus Pharmaceuticals, Inc.