Phase 3 N=327 Pediatric Schizophrenia Efficacy and Safety Study
Schizophrenia
Primary: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6. — 94.5; 94.0; 92.8; -18.6 units on a scale — p=0.0003
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=82 Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
Epilepsies, Partial
Primary: Number of Participants With Treatment-Related Adverse Events — 5 Participants
N/A N=111 Precedex Special Investigation (in Pediatric Patients)
Sedation
Primary: Number of Participants With Adverse Drug Reactions — 9; 2 Participants
N/A N=50 Sinus Balloon Dilation in Pediatric Patients
Sinusitis
Primary: Technical Success: Sinuses Successfully Treated With Balloon Dilation — 157 sinus dilation attempts
N/A N=89 Vfend Special Investigation For Pediatric - Observational
Pediatric Safety and Effectiveness
Primary: Number of Participants With Adverse Reactions — 23; 3 Participants
Phase 2 N=16 Paediatric Safety Study in Cat-PAD
Rhinoconjunctivitis
Primary: Number of Subjects With AEs — 5; 12 participants
Phase 2 N=112 Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
Acute Otitis Media
Primary: Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) — -4.3; -5.0; -4.6; -4.9 units on a scale
N/A N=149 Medication Education for Dosing Safety
Pain · Fever
Primary: Number of Participants Reporting Safe Dosing at 48-72 Hours — 28; 25 Participants
Phase 4 N=51 Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
Pain
Primary: To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years…
Phase 3 N=94 BAY81-8973 Pediatric Safety and Efficacy Trial
Haemophilia A
Primary: Annualized Number of Total Bleeds Within 48 h — 2.23; 1.86; 1.9 Bleeds
Phase 3 N=670 Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Postoperative Nausea and Vomiting
Primary: Proportion of Patients With Complete Response — 78.2; 82.7 percentage of patients
Phase 3 N=150 Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
Postoperative Nausea and Vomiting
Primary: Proportion of Patients With no Emetic Episodes in the Overall Time Period 0-72 Hours Post-operatively — 88.0; 84.0 percentage of patients
N/A N=44 Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
Chronic Sinusitis
Primary: Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months — 0 number of events
Phase 4 N=6 Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension · Hypertension, Pulmonary
Primary: Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Week 16 — 18.567; -4.113 wood units*meter^2
Phase 4 N=108 Pediatric Zylet Safety and Efficacy Study
Chalazion · Hordeolum
Primary: Treatment Emergent Adverse Events — 2; 0; 1; 1 participants
Phase 2 N=97 Pediatric Head Lice Study Product Comparison
Head Lice
Primary: Number of Participants Free of Live Head Lice and Free of Viable Eggs — 57; 55; 32; 46 Participants
Phase 3 N=100 Safety and Efficacy of Ferriprox™ (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients
Iron Overload
Primary: Occurrence of Adverse Events — 212 Adverse Events
Phase 3 N=137 Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
Influenza
Primary: Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events. — 22; 5; 2; 0 Participants
Phase 3 N=100 Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
Pain · Fever
Primary: Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE) — 1; 1; 5; 25 Subjects
Phase 3 N=502 Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients
Chemotherapy-Induced Nausea and Vomiting
Primary: Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1 — 54.2; 59.4; 58.6 percentage of patients
Phase 3 N=197 A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma
Asthma
Primary: Change From Baseline to Visit 4 in the Mean Daily Composite Score Based on the Pediatric Asthma Caregiver Assessments (PACA) — -1.21; -0.67; -0.52 units on a scale
N/A N=94 Parent Nurse Controlled Analgesic in Pediatric Patients With Developmental Delay
Post Operative Pain
Primary: Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale — 1.0; 1.8; 1.5 units on a scale
Phase 4 N=16 Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel
Periodontal Disease
Primary: Pharmacokinetics — 89.9; 41.8; 3.72; 5.13 ng/mL
Phase 4 N=124 Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
Constipation
Primary: Frequency of Spontaneous Bowel Movements — 2.47; 3.02; 3.84 spontaneous bowel movements per week
Phase 3 N=100 Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
Encephalitis
Primary: Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination — 33.3; 20.7; 3.4 percentage of participants
Phase 4 N=145 Safety and Efficacy of Iron Sucrose in Children
Anemia · Chronic Kidney Disease
Primary: Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event — 27; 25; 26 participants
Phase 3 N=97 Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL
Postoperative Pain Management
Primary: Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Infinity — 14246.1; 5709.4; 11569.5; 26164.0 ng*h/mL
Phase 4 N=229 Apixaban for the Acute Treatment of Venous Thromboembolism in Children
Venous Thromboembolism
Primary: Percentage of Participants With Composite of Major and Clinically Relevant Non-Major (CRNM) Bleeding — 1.3; 1.4 percentage of participants
Phase 4 N=25 Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute
Pain
Primary: Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years — 12; 0; 1; 1 participants
Phase 3 N=71 Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
Pain, Postoperative
Primary: Assessment Of Participant's Ability To Use The SSEC — 1; 2; 10; 48 participants