Clinical trials: Double-blind Randomized Controlled Study
Ulcerative Colitis
Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to <12 and 12 to ≤17 years) of budesonide rectal foam as compared to an…
- Trial name
- NCT05976802
- Testing
- High dose budesonide rectal foam, Low dose budesonide rectal foam
- Volunteers
- 100 people
- Sponsor
- Bausch Health Americas, Inc.
Atopic Dermatitis
Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product…
- Trial name
- NCT02896101
- Testing
- Pimecrolimus Cream, 1%, Elidel® (pimecrolimus) Cream
- Where
- 27 sites in United States
- Volunteers
- 755 people
- Sponsor
- Glenmark Pharmaceuticals Ltd. India
Malaria
Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali
Background: Malaria is a disease spread by mosquitos. Pregnant women are highly susceptible to malaria. This can lead to poor health outcomes for pregnant women and their babies.
- Trial name
- NCT03989102
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Mali
- Volunteers
- 324 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Asthma
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma
This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) administered via breath-actuated inhaler…
- Trial name
- NCT02040766
- Testing
- Beclomethasone dipropionate BAI, albuterol/salbutamol 90 mcg, Beclomethasone dipropionate MDI
- Where
- 102 sites in United States, Croatia and 3 more
- Volunteers
- 628 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Perennial Allergic Rhinitis
The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.
- Trial name
- NCT01861522
- Testing
- Bepotastine besilate
- Where
- 2 sites in Japan
- Volunteers
- 473 people
- Sponsor
- Tanabe Pharma Corporation
Cystic Fibrosis
Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients
The purpose of this study is to determine the effect of 24 weeks of treatment with BIIL 284 BS compared with placebo on pulmonary function and incidence of pulmonary exacerbation in adult and pediatric cystic fibrosis patients.
- Trial name
- NCT00060801
- Testing
- BIIL 283 BS (Amelubent)
- Where
- 35 sites in United States
- Volunteers
- 420 people
- Sponsor
- Boehringer Ingelheim
Acute Upper Respiratory Tract Infection
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory Tract Infections
The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S.
- Trial name
- NCT01537081
- Testing
- Mucinex, Immediate-release Guaifenesin
- Where
- 43 sites in United States
- Volunteers
- 2,810 people
- Sponsor
- Reckitt Benckiser LLC
Knee Osteoarthritis
Comparing Intra-articular Betamethasone (Diprospan) and Triamcinolone Acetonide Injection in Knee Osteoarthritis
The purpose of this study is to compare the efficacy of Intra-articular corticosteroid injection between Betamethasone (Diprospan) and Triamcinolone acetonide for treatment of knee osteoarthritis
- Trial name
- NCT05139875
- Testing
- Betamethasone Dipropionate / Betamethasone Sodium Phosphate, Triamcinolone Acetonide 40mg/mL
- Where
- Thailand
- Volunteers
- 105 people
- Sponsor
- Thammasat University
Migraine Disorders
Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
- Trial name
- NCT04748601
- Testing
- Qudexy XR
- Where
- 15 sites in United States
- Volunteers
- 132 people
- Sponsor
- Upsher-Smith Laboratories
Sickle Cell Disease
Voxelotor Neurocognitive Function Study
This is a Phase 3b, randomized, double-blind, placebo-controlled, multicenter study to assess the treatment effect of voxelotor on neurocognitive function as assessed by the National Institute of Health (NIH) Toolbox Cognition…
- Trial name
- NCT05228834
- Testing
- Voxelotor Only Product in Oral Dose Form
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Snakebites, Envenoming
Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite
This is a multicenter, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability and efficacy of varespladib-methyl, concurrently with standard of care (SOC), in subjects bitten by…
- Conditions
- Snakebites, Envenoming, Envenoming, Snake, Envenomation, Snake
- Trial name
- BRAVO (NCT04996264)
- Testing
- Varespladib Methyl, Standard of care (SOC)
- Where
- 16 sites in United States, India
- Volunteers
- 95 people
- Sponsor
- Ophirex, Inc.
Pertussis
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
OBJECTIVES: I. Compare the safety and efficacy of acellular 2-component vs. acellular multicomponent vs. whole-cell pertussis vaccine vs. placebo in infants living in Sweden. II.
- Trial name
- NCT00004799
- Testing
- whole-cell pertussis vaccine, diphtheria-tetanus vaccine
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Acne Vulgaris
Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris
Assessment of the efficacy and safety of CD5789 (trifarotene) 50μg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.
- Trial name
- NCT02566369
- Testing
- CD5789 (trifarotene) 50μg/g cream
- Where
- 124 sites in United States, Canada and 3 more
- Volunteers
- 1,208 people
- Sponsor
- Galderma R&D
Pulmonary Arterial Hypertension, Pulmonary Hypertension
Inhaled Nitric Oxide/INOpulse DS for Pulmonary Arterial Hypertension (PAH)
This is a Phase 2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo as Add-on Therapy in Symptomatic Subjects with…
- Trial name
- PAH (NCT01457781)
- Testing
- Inhaled Nitric Oxide 0.025 mg/kg IBW/hr delivered via INOpulse DS Device, Inhaled nitric oxide 0.075 mg/kg IBW/hr delivered via INOpulse DS Device
- Where
- 51 sites in United States, Canada
- Volunteers
- 80 people
- Sponsor
- Bellerophon Pulse Technologies
Rotavirus Gastroenteritis
A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.
- Trial name
- NCT02133690
- Testing
- Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)
- Where
- 6 sites in India
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Healthy
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety of MEDI-559 in Healthy 1 to <24 Month-Old Children
The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10^5 FFU when administered to healthy RSV seronegative children 1 to <24 months of age.
- Trial name
- MEDI-559 (NCT00767416)
- Testing
- MEDI-559
- Where
- 76 sites in United States, Puerto Rico
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Persistent Asthma
Study of Safety of Foradil in Patients With Persistent Asthma
The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and…
- Trial name
- NCT01845025
- Testing
- Formoterol 12 mcg, Fluticasone propionate 100 mcg, Fluticasone propionate 250 mcg
- Where
- 27 sites in United States
- Volunteers
- 827 people
- Sponsor
- Novartis Pharmaceuticals
Allergic Rhinitis
Assess the Efficacy and Safety of Rhinocort Aqua
The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.
- Trial name
- NCT00641693
- Testing
- Budesonide
- Volunteers
- 650 people
- Sponsor
- AstraZeneca
Attention Deficit Hyperactivity Disorder
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of…
- Trial name
- Zolkids (NCT00318448)
- Testing
- Zolpidem (SL800750)
- Where
- 2 sites in United States, Canada
- Volunteers
- 201 people
- Sponsor
- Sanofi
Prader-Willi Syndrome
A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome
This was a study investigating RAD011 in participants diagnosed with Prader-Willi Syndrome (PWS). The primary objective of the Phase 2 part of this study was to assess the safety and tolerability of multiple dose levels of RAD011…
- Trial name
- NCT05098509
- Testing
- RAD011
- Where
- 8 sites in United States
- Volunteers
- 4 people
- Sponsor
- Radius Pharmaceuticals, Inc.
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