Phase 2 and Phase 3 Experience
In the planning and execution of Phase 2 and Phase 3 clinical studies, PROMETRIKA has proven success in every major therapeutic area. Members of the PROMETRIKA team have collectively managed more than 80 Phase 2 and Phase 3 clinical studies, including frequent support related to DMC services. Delivered with outstanding strategic insight and perspective, our CRO services in Phase 2 and Phase 3 studies are designed to advance research efforts with maximum efficiency and the essential understanding that can help to reduce risk while producing high quality results.
Recent PROMETRIKA Phase 2 and Phase 3 experience includes:
| Therapeutic Area | Indication | Sample Size | Study Design |
|---|---|---|---|
| Allergy | Allergic Rhinitis | 200 | Double-blind, multi-center, placebo-controlled, parallel group study |
| Allergy | Allergic Rhinitis | 500 | Double-blind, multi-center, placebo-controlled, parallel group study |
| Allergy | Allergic Rhinitis | 200 | Double-blind, multi-center, placebo-controlled, parallel group study |
| Allergy | Allergic Rhinitis | 50 | Double-blind, multi-center, placebo-controlled, parallel group study |
| Allergy | Allergic Rhinitis | 400 | Double-blind, multi-center, placebo-controlled, parallel group study |
| Allergy | Allergic Rhinitis | 200 | Double-blind, multi-center, placebo-controlled, parallel group study |
| Anti-Infective | Anti-bacterial | 30 | Double-blind, randomized, placebo-controlled, sequential design study |
| Cardiology | Platelet Function Disorders | 30 | Single-center, open-label, pilot study |
| Cardiology | Complications of PCI | 900 | Randomized, multi-national, active-controlled, open-label study |
| Cardiology | Complications of CABG | 100 | Randomized, double-blind, placebo-controlled, parallel group, multi-center proof of concept study |
| Cardiology | Coronary Artery Disease | 100 | Open-label study |
| Cardiology | Hypercholesterolemia | 150 | Randomized, multi-center, double-blind, placebo-controlled, parallel group, dose-range finding study |
| Dermatology | Plaque Psoriasis | 300 | Open-label, multi-center study |
| Dermatology | Atopic Dermatitis | 150 | Open-label, treatment continuation study |
| Dermatology | Acne Vulgaris | 100 | Randomized, double-blind, multi-center, placebo-controlled, parallel-group, proof of concept study |
| Dermatology | Atopic Dermatitis | 60 | Multi-center, randomized, controlled, double-blind study |
| Dermatology | Atopic Dermatitis | 200 | Multi-center, randomized, double-blind, placebo-controlled, parallel group study |
| Dermatology | Atopic Dermatitis | 350 | Randomized, double-blind, placebo-controlled, parallel group study |
| Dermatology | Psoriasis | 200 | Multi-center, randomized, double-blind, placebo-controlled study |
| Dermatology | Plaque Psoriasis | 20 | Single-center, randomized, vehicle-controlled, blinded, exploratory study |
| Dermatology | Atopic Dermatitis | 200 | Open-label, treatment continuation study |
| Dermatology | Atopic Dermatitis | 40 | Open-label study |
| Endocrinology | Diabetes | 150 | Multi-center, randomized study |
| Endocrinology | Diabetes | 500 | Multi-center, double-blind, placebo-controlled, parallel group study |
| Endocrinology | Diabetes | 500 | Multi-center, double-blind, placebo-controlled, parallel group study |
| Gastroenterology | Crohn's Disease | 1100 | Randomized, multi-center, blinded, placebo-controlled study |
| Gastroenterology | IBS with Constipation or Chronic Constipation | 1700 | Open-label, long-term safety study |
| Gastroenterology | Chronic Constipation | 600 | Randomized, double-blind, placebo-controlled, parallel group study |
| Gastroenterology | IBS with Constipation | 800 | Randomized, double-blind, placebo-controlled, parallel-group study |
| Gastroenterology | Ulcerative Colitis | 800 | Randomized, multi-center, blinded, placebo-controlled study |
| Gastroenterology | Chronic Constipation | 300 | Randomized, multi-center, double-blind, placebo-controlled, dose-range-finding study |
| Gastroenterology | IBS with Constipation | 400 | Randomized, multi-center, double-blind, placebo-controlled, dose-range-finding, parallel design trial |
| Gastroenterology | Ulcerative Colitits and Crohn's | 1900 | Open-label, long-term safety and efficacy study |
| Neurology | Multiple Sclerosis | 200 | Double-blind, placebo-controlled, parallel group study |
| Neurology | Multiple Sclerosis | 250 | Multi-center, randomized, two arm study |
| Neurology | Multiple Sclerosis | 300 | Open-label extension study |
| Neurology | Multiple Sclerosis | 300 | Double-blind, placebo-controlled, parallel group study |
| Neurology | Multiple Sclerosis | 100 | Randomized, multi-center, two arm, open-label study followed by a safety extension |
| Neurology | Multiple Sclerosis | 200 | multi-center, open-label extension study |
| Neurology | Multiple Sclerosis | 200 | open-label extension study |
| Neurology | Multiple Sclerosis | 100 | Randomized, multi-center, two arm, open label study followed by a safety extension |
| Neurology | Acute Pain | 1000 | Open-label, multiple-dose, multiple-day, single arm study |
| Neurology | Acute Pain | 350 | Seven treatment arm, randomized, double-blind, single-dose, and placebo- and comparator controlled, parallel-group study |
| Neurology | Acute Pain | 250 | Randomized, multi-center, double-blind, placebo-controlled study |
| Neurology | Acute Pain | 300 | Randomized, double-blind, active- and placebo-controlled study |
| Neurology | Tourette's Syndrome | 60 | 3 studies: a phase 2, double-blind proof of concept study, a phase 2, open-label extension study and a phase 3, double-blind, proof of efficacy study |
| Neurology | Acute Pain | 250 | Multi-center, randomized, double-blind, three-arm, active-and placebo-controlled study |
| Oncology | Melanoma | 80 | Randomized, open-label study |
| Oncology | Sarcoma | 10 | Single-center, parallel group, open-label study |
| Oncology | Ovarian Cancer | 50 | Multi-center, parallel group, open-label study |
| Oncology | Prostate Cancer | 50 | Multi-center, parallel group, open-label study |
| Oncology | Malignant Pheochromocytoma/Paraganglioma | 80 | Multi-center, single arm, open-label study |
| Oncology | Non-Small Cell Lung Cancer | 200 | Multi-center, randomized, double-blind, placebo-controlled study |
| Oncology | Malignant Pheochromocytoma/Paraganglioma | 60 | Multi-national, multi-center, single arm, open-label study |
| Oncology | Acute Myelogenous Leukemia | 400 | Randomized, double-blind, multi-center, placebo-controlled, parallel group study |
| Oncology | Peripheral T cell Lymphoma | 90 | Open-label, multi-center, single arm study |
| Oncology | Colorectal Cancer | Multi-center, randomized, double-blind, placebo- and active-controlled, parallel group study | |
| Oncology | Renal Cell Carcinoma | 25 | Single-center, cohort study |
| Oncology | Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma | 20 | Open-label, fixed dose |
| Pulmonary | COPD | 30 | Single-center, double-blind, placebo-controlled, crossover study |
| Pulmonary | COPD | 30 | Single-center, double-blind, placebo-controlled, crossover study |
| Pulmonary | COPD | 30 | Single-center, double-blind, placebo-controlled, crossover study |
| Pulmonary | COPD | 30 | Single-center, double-blind, placebo-controlled, crossover study |
| Pulmonary | Asthma | 400 | Randomized, double-blind, active-controlled, parallel group study |
| Pulmonary | Asthma | 60 | Single-center, double-blind, placebo-controlled, crossover study |
| Pulmonary | Asthma | 30 | Single-center, double-blind, placebo-controlled, crossover study |
| Pulmonary | Asthma | 150 | Randomized, double-blind, placebo-controlled, five-way crossover study |
| Pulmonary | COPD | 400 | Randomized, double-blind, placebo-controlled, parallel group study |
| Pulmonary | Asthma | 100 | Multi-center, double-blind, randomized, placebo-controlled study |
| Pulmonary | Asthma | 60 | Multi-center, randomized, double-blind, placebo-controlled, single-dose, sequential group, dose-escalating study |
| Pulmonary | Asthma | 25 | Uncontrolled, multi-center, open-label study |
| Pulmonary | COPD | 2000 | Multi-national, randomized, double-blind, placebo- and active-controlled, parallel group study |
| Pulmonary | Asthma | 40 | Multi-center, randomized, double-blind, placebo-controlled, single-dose, three-period crossover study |
| Rheumatology | Osteoarthritis | 300 | Multi-center, randomized, double-blind, placebo-controlled study |
| Rheumatology | Osteoarthritis | 250 | Multi-center, open-label extension study |
| Rheumatology | Rheumatoid Arthritis | 100 | Multi-center, double-blind, parallel group, randomized, placebo-controlled study |
| Urology | Chronic Kidney Disease | 40 | Multi-center, randomized, double-blind, placebo-controlled, dose escalation study |
| Urology | Hypoactive Sexual Desire Disorder | 600 | Randomized discontinuation study containing an open-label, flexible dose period followed by a double-blind, randomized, placebo-controlled period |