Clinical trials: Double-blind Randomized Controlled Study
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Glycogen Storage Disease Type IA
A Study of Adeno-Associated Virus Serotype 8-Mediated Gene Transfer of Glucose-6-Phosphatase in Patients With Glycogen Storage Disease Type Ia (GSDIa)
The primary objectives of this study are to evaluate the efficacy of DTX401 to reduce or eliminate dependence on exogenous glucose replacement therapy to maintain euglycemia and to maintain or improve the quality of glucose…
- Trial name
- NCT05139316
- Testing
- DTX401, Oral prednisolone
- Where
- 20 sites in United States, Brazil and 7 more
- Volunteers
- 52 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Acne Vulgaris
A Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
Enrollment of subjects with mild to moderate facial acne vulgaris. Co-Primary efficacy endpoints included: Absolute change from Baseline to Week 12 in the inflammatory lesion counts on the face Absolute change from Baseline to…
- Trial name
- NCT03292640
- Testing
- DFD-03 (0.1% tazarotene) Lotion
- Where
- United States
- Volunteers
- 547 people
- Sponsor
- Dr. Reddy's Laboratories Limited
Cystic Fibrosis
A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)
- Trial name
- NCT03525548
- Testing
- VX-445/TEZ/IVA, TEZ/IVA, IVA
- Where
- 44 sites in United States, Belgium and 2 more
- Volunteers
- 113 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Neonatal Encephalopathy
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Around the time of birth, some babies experience a condition called asphyxia, which means that their brain and other organs do not receive enough blood and/or oxygen to work properly.
- Trial name
- NCT06098833
- Testing
- Sildenafil, Ora-Blend
- Where
- 3 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Pia Wintermark
Vibrio Cholerae, Cholera
Bridging Study for Killed Oral Cholera Vaccine in Ethiopia
This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia.
- Trial name
- NCT01524640
- Testing
- Killed Bivalent (O1 and O139) whole cell oral cholera vaccine
- Where
- Ethiopia
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Rhinitis, Allergic, Seasonal
7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis
This is a study of the effectiveness and safety of a new nasal spray for the relief of the symptoms of seasonal allergies. The agents being compared are: R926112 (a novel anti-allergy medicine), Beconase (beclomethasone…
- Trial name
- NCT00115089
- Testing
- R926112, Beclomethasone dipropionate
- Volunteers
- 375 people
- Sponsor
- Rigel Pharmaceuticals
Obesity, Over-weight
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.
- Conditions
- Obesity, Over-weight, Prader-Willi Syndrome
- Trial name
- NCT01818921
- Testing
- ZGN-440 sterile diluent, 1.2 mg ZGN-440 for injectable suspension, 1.8 mg ZGN-440 for injectable suspension
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Zafgen, Inc.
Cow Milk Protein Allergy
Growth And Safety Outcomes In Infants With Cow´s Milk Protein Allergy (CMPA) Fed A Novel Extensively Hydrolyzed Formula (eHF)
Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula.
- Trial name
- NCT07711938
- Testing
- New generation eHF, Commercial eHF
- Volunteers
- 410 people
- Sponsor
- Société des Produits Nestlé (SPN)
Acute Bronchitis
Efficacy of Elixirium Thymi Compositum in the Treatment of Acute Bronchitis in Pediatric Patients
The aim of this study is to evaluate the efficacy and safety of Elixirium thymi compositum (Formulae Normales (FoNo) VIII.) compared to a placebo in children between 6 and 17 years old to treat their acute bronchitis.
- Trial name
- EXOTIC (NCT07030855)
- Testing
- Elixirium thymi compositum (FoNo VIII.)
- Where
- Hungary
- Volunteers
- 56 people
- Sponsor
- Semmelweis University
Seasonal Allergic Rhinitis
A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies
The purpose of this study was to determine if two allergy medications are more effective than placebo.
- Trial name
- NCT00720278
- Testing
- 0.15% azelastine hydrochloride 1644 mcg daily, 0.1% azelastine hydrochloride 1096 mcg daily
- Where
- 29 sites in United States
- Volunteers
- 526 people
- Sponsor
- Meda Pharmaceuticals
Cystic Fibrosis
Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway infection.
- Trial name
- KB001-A (NCT01695343)
- Testing
- KB001-A
- Where
- 67 sites in United States, Australia and 2 more
- Volunteers
- 182 people
- Sponsor
- Humanigen, Inc.
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Impetigo
Vehicle Controlled Efficacy and Safety Study of Two Dose Regimens of CD07223 1.5% Topical Gel in Impetigo
This study will be a multicenter, randomized, vehicle controlled, parallel, group, double blind study. Eligible subjects with a clinical diagnosis of impetigo will be randomized to one of four treatment groups: 1.5% CD07223…
- Trial name
- NCT01670032
- Testing
- Experimental: CD07223 1.5 % Topical Gel BID, Experimental: CD07223 1.5% Topical Gel TID
- Where
- 13 sites in United States, South Africa
- Volunteers
- 328 people
- Sponsor
- NovaBay Pharmaceuticals, Inc.
Cystic Fibrosis, Prediabetes
Prevention of Cystic Fibrosis Diabetes
Acute systemic hyperglycemia causes oxidative stress and a pro-inflammatory response. The pro-inflammatory cytokines induced by hyperglycemia are toxic to islet insulin producing cells, and thus worsen glucose intolerance.
- Trial name
- Prevent (NCT00967798)
- Testing
- Sitagliptin
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Emory University
Otitis Media With Effusion
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
- Trial name
- NCT01949155
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
Tourette Syndrome
Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
This is a Phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety and maintenance of efficacy of an optimized once-daily (qd) dose of NBI-98854 in pediatric subjects with TS.
- Trial name
- NCT03530293
- Testing
- Valbenazine
- Where
- 49 sites in United States, Puerto Rico
- Volunteers
- 81 people
- Sponsor
- Neurocrine Biosciences
Ulcerative Colitis
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis…
- Trial name
- NCT05507216
- Testing
- ABX464
- Where
- 262 sites in United States, Argentina and 25 more
- Volunteers
- 636 people
- Sponsor
- Abivax S.A.
Ulcerative Colitis, Gastrointestinal Disease
Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis
The purpose of The PROSPECT Study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis.
- Conditions
- Ulcerative Colitis, Gastrointestinal Disease, Inflammatory Bowel Disease
- Trial name
- NCT00073047
- Testing
- Daclizumab
- Where
- 35 sites in United States, Belgium and 1 more
- Volunteers
- 150 people
- Sponsor
- Facet Biotech
Asthma
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care
- Trial name
- KALOS (NCT04609878)
- Testing
- BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg
- Where
- 360 sites in United States, Argentina and 19 more
- Volunteers
- 2,274 people
- Sponsor
- AstraZeneca
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