Clinical trials: Oral
Neuroblastoma
Oral Liquid 13-cis-retinoic Acid (13-CRA)
An open label, randomised, multiple dose, cross-over relative bioavailability and pharmacokinetics trial of a novel oral liquid and capsule formulations of 13-CRA administered to patients from 0 months - < 21 years.
- Trial name
- My-CRA (NCT03291080)
- Testing
- Liquid 13-Cis Retinoic Acid, Extracted capsules 13-CRA
- Where
- 10 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Nova Laboratories Limited
Contraception
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
- Trial name
- NCT01181479
- Testing
- AG200-15 (cycles 1-13), Lessina crossover to AG200-15
- Where
- 80 sites in United States
- Volunteers
- 1,504 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Diabetes Mellitus, Type 1
Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Type 1 diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the…
- Trial name
- TN07 (NCT00419562)
- Testing
- Oral Insulin
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 560 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Peanut Allergy
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing…
- Trial name
- NCT03682770
- Testing
- Dupilumab, AR101
- Where
- 25 sites in United States
- Volunteers
- 148 people
- Sponsor
- Regeneron Pharmaceuticals
Adolescent Idiopathic Scoliosis
Oral Caffeine Use for Pain Management in AIS Patients After Spinal Fusion
Prospective, randomized control trial To determine if oral caffeine decreases the frequency of opioid demand in children with adolescent idiopathic scoliosis after their spinal fusion surgery To compare pain scale ratings, number…
- Trial name
- NCT04950660
- Testing
- Caffeine Tablet
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Children's Mercy Hospital Kansas City
Infections, Rotavirus
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after…
- Trial name
- NCT01198769
- Testing
- Rotarix TM
- Where
- Taiwan
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Milk Allergy
The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.
- Trial name
- NCT00732654
- Testing
- Milk Protein Extract Immunotherapy goal of 4mg/day, Milk Protein Extract Immunotherapy goal of 7mg/day, Milk Powder Immunotherapy goal dose 2000 mg/day
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Johns Hopkins University
Recurrent Vulvovaginal Candidiasis
A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months.
- Trial name
- VIOLET (NCT03562156)
- Testing
- Oteseconazole (VT-1161)
- Where
- 25 sites in United States
- Volunteers
- 438 people
- Sponsor
- Mycovia Pharmaceuticals Inc.
Cholera (Disorder)
VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1.
- Trial name
- NCT03220737
- Testing
- VAXCHORA (Cholera Vaccine, Live, Oral)
- Where
- 10 sites in United States
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Infections, Rotavirus
Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)
This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human…
- Trial name
- NCT00329745
- Testing
- Rotarix™
- Where
- 4 sites in Singapore
- Volunteers
- 8,687 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Anaplastic Astrocytoma, Brain Stem Glioma
Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas
This phase I/II trial studies the side effects and the best dose of veliparib when given together with radiation therapy and temozolomide and to see how well they work in treating younger patients newly diagnosed with diffuse…
- Conditions
- Anaplastic Astrocytoma, Brain Stem Glioma, Childhood Mixed Glioma, Fibrillary Astrocytoma
- Trial name
- NCT01514201
- Testing
- 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis
- Where
- 12 sites in United States
- Volunteers
- 66 people
- Sponsor
- National Cancer Institute (NCI)
Gonorrhea
Zoliflodacin in Uncomplicated Gonorrhoea
This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg…
- Trial name
- NCT03959527
- Testing
- zoliflodacin, ceftriaxone, azithromycin
- Where
- 17 sites in United States, Belgium and 3 more
- Volunteers
- 1,011 people
- Sponsor
- Global Antibiotics Research and Development Partnership
Fabry Disease
Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease
The primary objective of this study was to compare the effect of migalastat (123 milligrams [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) versus placebo on kidney globotriaosylceramide (GL-3).
- Trial name
- NCT00925301
- Testing
- migalastat hydrochloride
- Where
- 28 sites in United States, Argentina and 11 more
- Volunteers
- 67 people
- Sponsor
- Amicus Therapeutics
HIV Infection
A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)
This multicenter, open-label, noncomparative study evaluates two oral formulations of raltegravir (MK-0518, film-coated tablet and chewable tablet) in combination with other antiretroviral agents for safety, tolerability, and…
- Trial name
- NCT01717287
- Testing
- Raltegravir Film-coated Tablet, Raltegravir Chewable Tablet, Other Anti-Retroviral Therapy
- Volunteers
- 32 people
- Sponsor
- Merck Sharp & Dohme LLC
Inflammatory Breast Cancer, Male Breast Cancer
Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer
This phase II trial studies how well giving sunitinib malate together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients with stage IIB-IIIC breast cancer.
- Conditions
- Inflammatory Breast Cancer, Male Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
- Trial name
- NCT00513695
- Testing
- sunitinib malate, paclitaxel, doxorubicin hydrochloride
- Where
- 7 sites in United States
- Volunteers
- 68 people
- Sponsor
- University of Washington
Sickle Cell Disease, Sickle-Cell; Hemoglobin Disease, Thalassemia
Pharmacokinetics of Oral Hydroxyurea Solution
An open label, safety and pharmacokinetic study of oral hydroxyurea solution administered to children from 6 months to 17.99 years (i.e.
- Conditions
- Sickle Cell Disease, Sickle-Cell; Hemoglobin Disease, Thalassemia, Sickle Cell-beta-thalassemia, Sickle Cell Hemoglobin C
- Trial name
- HUPK (NCT03763656)
- Testing
- Oral Hydroxyurea (100 mg/mL) Solution
- Where
- 6 sites in Jamaica, United Kingdom
- Volunteers
- 33 people
- Sponsor
- Nova Laboratories Limited
Erythema Migrans, Post-Lyme Disease Symptoms
Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome
Background: While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult patients with erythema migrans has been…
- Trial name
- NCT01518192
- Testing
- doxycycline, cefuroxime axetil
- Where
- 2 sites in Slovenia
- Volunteers
- 544 people, healthy volunteers welcome
- Sponsor
- University Medical Centre Ljubljana
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
Schizophrenia, Bipolar Disorder
Aripiprazole Open-Label, Safety and Tolerability Study
The purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode.
- Trial name
- APEX 241 (NCT00102518)
- Testing
- Aripiprazole
- Where
- 50 sites in United States
- Volunteers
- 325 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Asthma, Wheezing
Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.
This protocol is comprised of two separate, but linked, clinical trials for treating preschool-aged children with recurrent severe episodes of wheezing.
- Trial name
- APRIL - OCELOT (NCT01272635)
- Testing
- Azithromycin, Prednisolone
- Where
- 16 sites in United States
- Volunteers
- 607 people
- Sponsor
- Milton S. Hershey Medical Center