Phase II Clinical Trial Experience
Below is a cumulative list of Page II Trials
A Phase II A,
6-week, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety, Tolerability and Pharmacodynamics of Oral XXXXX Administered with Canagliflozin In Adult Subjects with Type 2 Diabetes Mellitus.
A Phase II A,
Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of XXXXX Administered in Combination with Allopurinol Compared with Allopurinol Administered Alone in Adult Subjects with Gout.
A Phase II A,
Double Blind, Placebo Within-Patient Controlled, Multi-Center Dose Ranging Study to Evaluate the Safety and Preliminary Efficacy of XXXXX Drug Product in Trocar Sites of Arthroscopic Shoulder Surgery Patients.
A Phase II A,
Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study of XXXXX for the Management of Visceral Pain in Subjects Undergoing Sedation-Free, Full Colonoscopy.
A Phase II B,
Randomized, Double-Blind, Vehicle-Controlled, Repeat-Dose, Multi-Center, Efficacy and Safety Clinical Trial of Topically Applied XXXXX Gel in Subjects with Moderate to Severe Pain Associated with Osteoarthritis of the Knee Following Cessation of Pain Therapy.
A Phase II B,
Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of XXXXX, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (XXXXX) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.
A Phase II,
Double-Blind, Placebo-Controlled Study of Tricaprilin (XXXXX) Administered for Ninety Days in Subjects with Age-Associated Memory Impairment.
A Phase II,
MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, DOSE-FINDING AND SAFETY STUDY OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2)/CALCIUM PHOSPHATE MATRIX(CPM) IN SUBJECTS WITH DECREASED BONE MINERAL DENSITY.
A Phase II,
Randomized, Multiple-Dose, Crossover Study Characterizing the Pharmacodynamic Profiles of Formoterol Fumarate Inhalation Solution and Formoterol Dry Powder Inhaler in Subjects with Stable Chronic Obstructive Pulmonary Disease.
A Phase II,
Open-Label, Single-Dose, Parallel-Group Study of The Pharmacokinetics and Safety of Bosutinib In Subjects with Renal Impairment and Matched Healthy Adults.
Phase II,
Open-label, Single-dose, Randomized, Two-way (Two-period) Crossover Study to Compare the Pharmacokinetics and Bioavailability of a Novel Furosemide Regimen Administered Subcutaneously Versus the Same Dose (80mg) Administered Intravenously in Subjects with Chronic Heart Failure.
A Phase II,
EVALUATION OF THE SAFETY AND EFFICACY OF TREATMENT WITH SINGLE DOSES OF CHF XXXXX pMDI IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 5-Way Crossover Study.
A Phase II,
Randomized, Double-Blind, Vehicle-Controlled, Efficacy and Safety Clinical Trial of Topically Applied XXXXX Gel in Subjects with Moderate to Severe Pain Associated with Osteoarthritis of the Knee Following Cessation of Pain Therapy.
A Phase II,
EVALUATION OF THE Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Absorbed XXXXX in Healthy Adolescents, Adults, and Older Adults.
A Phase II,
PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TWO 3-DOSE REGIMENS OF A CLOSTRIDIUM DIFFICILE VACCINE IN HEALTHY ADULTS AGED 65 TO 85 YEARS.
A Phase II,
Randomized, Double-blind, Placebo-and-Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of XXXXX in Subjects with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee.
A Phase II,
Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of XXXXX Given as Monotherapy to Adults With Type 2 Diabetes Mellitus.
A Phase II,
International, Multi-center, Blinded, Randomized Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Administration of Regimens Containing XXXXX, XXXXX, and Ribavirin in Patients with Chronic Hepatitis C Virus (HCV) Infection.
A Phase II,
Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of XXXXX in Combination with Pegylated Interferon and Ribavirin in Treatment-Naive Patients with Chronic HCV Infection Genotype 1,4, 5, or 6.
A Phase II,
Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy, Safety and Tolerability of XXXXX Following Multiple Intravenous Doses in Hypercholesterolemic Subjects on High Doses of Atorvastatin, Rosuvastatin Or Simvastatin.
A Phase II,
Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetic Parameters of XXXXX in Subjects with Persistent Mild to Moderate Asthma.
A Phase II,
Randomized, Double-Blind, Placebo-Controlled Study of XXXXX, XXXXX, Tegobuvir and Ribavirin (RBV) Compared With XXXXX, XXXXX With Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection.
A Phase II,
Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy, Safety and Tolerability of XXXXX Following Multiple Intravenous Doses in Hypercholesterolemia Subjects on Maximum Dose of Atorvastatin or Rosuvastatin.
A Phase II,
Multicenter, Open-Label Study of the Long-Term Safety of XXXXX Foam 0.3% in Subjects with Seborrheic Dermatitis.
A Phase II,
Multicenter, prospective, randomized, placebo controlled, adaptive design study performed to evaluate the safety and the efficacy of XXXXX in debridement of Venous Leg Ulcers.
A Phase II,
Multicenter, Randomized, Double blind, Vehicle-controlled, Phase 2 Efficacy and Safety Study of XXXXX Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Patients with Non-Gorlin High Frequency Basal Cell Carcinoma.
A Phase II,
Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, and Branebrutinib Treatment Alone and in Combination with Abatacept in Subjects with Active Rheumatoid Arthritis.
A Phase II,
Expanded Access Protocol studying the effects of XXXXX for the treatment of adolescents and adults with moderate to severe Atopic Dermatitis.