The team at the Medical Sciences Research Institute has been part of the research teams who have conducted the following trials:
- V503-002. A phase III study A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 years of age) compared to young female subjects (16 to 26 years of age).
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- Identification and characterization, including serotyping and evaluation of antimicrobial sensitivity of Acute Otitis Media (AOM)-causing bacteria in Costa Rican subjects (≥ 3 months to < 5 years of age) before and after the use of pneumococci conjugated vaccine (PCV-7) in the national immunization program.
- A3191342. A Phase 4, 6-week, Randomized Double Blind, Multicenter, Active-controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis.
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- A3L24. A Phase 3, multicentric, randomized, blinded (double-blind regarding the three different lots of the research vaccine), conducted on 1376 breast-feeding infants using Infanrix hexa™ as a control vaccine. Four group study; subjects will be randomized to receive 1 of 3 batches of the DTaP-IPV-Hep B-PRP-T vaccine (consistency analysis) or the authorized control vaccine Infanrix hexa™ (non-inferiority analysis). All subjects will receive Prevenar™ and Rotarix™ concomitantly with the DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.
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- V59P23. A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants.
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- V112_04. A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years.
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- A Prospective, Multi Center, Non-randomized Clinical Trial to Evaluate the Ear Effusion Detection and Characterization System (EEDCS) to Detect and Characterize Middle Ear Fluid in Children.
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- V59P18. A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents.
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- BC20963: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.
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- BC21893: A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea.
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- BO20603: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Comparing the Efficacy of Bevacizumab in Combination With Rituximab and CHOP (R-CHOP + Bevacizumab) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL).
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- WA17047: A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis.
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- BO17920: A Randomized, Three Arm Multinational Phase III Study to Investigate Bevacizumab (q3w or q2w) in Combination With Either Intermittent Capecitabine Plus Oxaliplatin (XELOX) (q3w) or Fluorouracil/Leucovorin With Oxaliplatin (FOLFOX-4) Versus FOLFOX-4 Regimen Alone as Adjuvant Chemotherapy in Colon Carcinoma: The AVANT Study.
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- Liberate 32974: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Investigate Safety and Efficacy of Tibolone (Org OD14) in Women With Climacteric Symptoms and a History of Breast Cancer.
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- CP045/06/FCNS: A Multicenter, Placebo-Controlled, Double-Blind, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy.
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- CP043/06/FCNS: A Multicenter, Placebo-Controlled, Double-Blind, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy.
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- 109MS302: A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis.
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- BAP00248: A Phase 3 Randomized Double-Blind Study Of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia.
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- BAP00414: A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections.
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- XRP1526B/3031: A Multinational,Multicenter,Randomized,Double-Blind,Placebo-Controlled,Parallel-Group Study to Assess the Efficacy of Ciclesonide Metered-Dose Inhaler at a Daily Dose of 160 μg Administered Either in a Once-Daily in the Morning Regimen (160 μg qd AM) for 16 Weeks or in a 160 μg qd AM Regimen for 12 Weeks Preceded by a Twice-Daily Regimen (80 μg Bid) for 4 Weeks,or in an 80 μg Bid Regimen for 16 Weeks,in Adults and Adolescents With Mild to Moderate Persistent Asthma Not Treated With Steroids.
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- D1447C00134: Multicenter, Double-blind, Randomized, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate (Seroquel®, single oral dose of 300 mg or 600 mg) & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation for 26 to 52 weeks.
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- Liberate 32974: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Investigate Safety and Efficacy of Tibolone (Org OD14) in Women With Climacteric Symptoms and a History of Breast Cancer.
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- Lift 32962: A Multinational, Multicenter, Randomized, Double-Blind, Parallel Group,Placebo Controlled Clinical Trial of the Effects of Tibolone (Org OD-14 1.25mg) on the Incidence of New Vertebral Fractures in Osteoporotic Postmenopausal Women.
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- LOFBO-LTSS-001: A Multicenter, Long-Term, Active-Surveillance Study of Musculoskeletal Disorders That Occur After Initiating a Course of Levofloxacin (RWJ-25213-097) or Non-Fluoroquinolone Therapy for Acute Infectious Diseases in Children Who Were Enrolled in Phase 3 Clinical Trials Involving Levofloxacin Therapy.
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- CSPP100E2337: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality.
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- CSPV100AUS02: An 8 Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active Controlled Study to Evaluate the Antihypertensive Efficacy and Safety of Aliskiren Administered in Combination With Valsartan Versus Valsartan Alone in Patients With Stage 2 Systolic Hypertension and Type 2 Diabetes Mellitus.
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- A3191172: A Randomized, Double Blind, Parallel-Group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen.
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