Phase 3 N=21 Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
Pediatric Ulcerative Colitis
Primary: Percent of Patients Who Achieved CAI Remission — 60.0; 80.0; 80.0; 77.8 percentage of participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=110 Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients
Severe Hemophilia A
Primary: Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors — 17; 11; 28 Participants
Phase 3 N=105 Evaluation of Celecoxib Effects on Amlodipine in Subjects With Existing Hypertension Requiring Antihypertensives
Hypertension
Primary: Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) — -8.0; -9.8 mmHg — p=0.024
Phase 3 N=151 Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects
Pain · Cancer
Primary: Summary of Pain Intensity Differences (SPID) — 47.9; 38.1 Score on a scale — p=0.004
Phase 3 N=1,040 Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
Constipation
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 817; 104 Participants
Phase 3 N=124 A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity
Spasticity, Post-Stroke
Primary: Percentage of Participants Who Had Modified Ashworth Scale (MAS) Score Reduced at Least 1 From Baseline in the Elbow Flexors at Week 6 — 50.8; 68.9 Percentage of…
Phase 3 N=545 Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis
Plaque Psoriasis
Primary: Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12 — 203; 211…
Phase 3 N=371 A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
Leukemia, Acute Myeloid (AML)
Primary: Duration of Overall Survival (OS) — 9.3; 5.6 Months — p=0.0004
Phase 3 N=111 A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
Cystic Fibrosis
Primary: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) — 0.3; 10.2 percentage points — p=< 0.0001
Phase 3 N=285 Safety and Efficacy of Suvorexant (MK-4305) for the Treatment of Insomnia in Participants With Alzheimer's Disease (MK-4305-061)
Sleep Initiation and Maintenance Disorders · Alzheimer Disease
Primary: Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4 — 73.4; 45.2 Minutes — p=0.00128
Phase 3 N=588 Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
Prostate Cancer
Primary: 5-Year Freedom From Progression Rate — 85.5; 83.1 percentage of participants — p=0.21
Phase 3 N=129 Clinical Usability of Intranasal Glucagon in Treatment of Hypoglycemia
Hypoglycemia · Diabetes Mellitus · Drug-Specific Antibodies
Primary: Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration — 95.7 percentage of participants
Phase 3 N=117 Improving Outcomes in Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome · Neonatal Opioid Withdrawal
Primary: Length of Hospital Stay (LOS) — 21.8; 23.2 days
Phase 3 N=51 Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome
Genetic Disorder · Noonan Syndrome
Primary: Change in Height SDS (Japanese National Reference Data) — 0.84; 1.47 Standard deviation score — p=< 0.0001
Phase 3 N=1,600 Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Infections, Rotavirus · Rotavirus Vaccines
Primary: Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C) — 155.7; 147.3…