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Study ID Status Title Patient Level Data
25000/611 Completed A Randomized, Investigator-Blind, Multicenter Study to Assess the Efficacy of Oral AUGMENTIN ES-600 Twice Daily for 10 Days Versus Oral Zithromax Once Daily for 5 Days in the Treatment of Acute Otitis Media in Infants and Children. Study Listed on ClinicalStudyDataRequest.com
25000/620 Completed A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Oral Augmentin SR 2000/125mg Twice Daily Versus Oral Augmentin 875/125mg Three Times Daily for 7 or 10 Days in the Treatment of Adults with Community Acquired Pneumonia of Suspected Pneumococcal Origin. Study Listed on ClinicalStudyDataRequest.com
25000/627 Completed A randomized, double-blind, multicentre, parallel group study to assess the efficacy and safety of oral Augmentin SR 2000/125mg twice daily for 5 days versus a 7-day regimen in the treatment of acute exacerbation of chronic bronchitis Study Listed on ClinicalStudyDataRequest.com
25000/630 Completed A randomised, double-blind, double-dummy, multicentre, parallel group study to assess the efficacy and safety of oral Augmentin SR 2000/125mg twice daily for 5 days versus oral Augmentin 875/125mg twice daily for 7 days in the treatment of adults with acute exacerbations of chronic bronchitis. Study Listed on ClinicalStudyDataRequest.com
25000/643 Completed A bioequivalence study to compare the currently marketed formulation of augmentin with the ES 600 Strawberry Cream Suspension (4A) Study Listed on ClinicalStudyDataRequest.com
25000/654 Completed A Phase III open-label, non-comparative study of BRL25000 ES-600 in paediatric patients with otitis media
25000/665 Completed An open-label, randomized, period balanced, replicate, four-period crossover bioequivalence study comparing AUGMENTIN ES-600 strawberry cream formulation to the marketed suspension. Study Listed on ClinicalStudyDataRequest.com
25000/668 Completed An uncontrolled, phase I study to determine ex vivo the serum bactericidal activity against Streptococcus pneumoniae with decreased susceptibility to amoxicillin in the presence of factors of non-specific immunity with and without specific antibodies, the urine bactericidal activity against Escheric
257049/005 Completed Phase IIb controlled randomised double-blind study to evaluate the efficacy, safety and immunogenicity of SmithKline Beecham Biologicals’ candidate RTS,S malaria vaccine in semi-immune adult males in The Gambia.
257049/015 Completed Staggered study to evaluate safety and immunogenicity of GSK Biologicals RTS,S/AS02 candidate malaria vaccine, administered intramuscularly according to a 0,1,3-month schedule in semi-immune children aged 6 to 11 years in Gambia, a malaria endemic region Study Listed on ClinicalStudyDataRequest.com
257049/020 Completed Staggered study to evaluate safety & immunogenicity of GSK Biologicals RTS,S/AS02 candidate malaria vaccine, administered intramuscularly according to 0,1,3-month schedule in toddlers and children aged 1 through 5 years in Gambia, a malaria endemic region
257049/025 Completed A phase I, double-blind, randomized, controlled, study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ candidate vaccine, administered intramuscularly according to a 0, 1, 2-month vaccination schedule in children aged 1 through 4 Study Listed on ClinicalStudyDataRequest.com
257049/026 Completed A study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals’ candidate malaria vaccine RTS,S/AS02A, administered intramuscularly according to a 0, 1 and 2 month vaccination schedule in toddlers and children aged 1 to 4 years in a malaria-endemic region of Mozambique. Study Listed on ClinicalStudyDataRequest.com
257049/027 Completed Double-blind, randomized phase I/IIa human challenge study, to evaluate the safety, reactogenicity, immunogenicity, and preliminary efficacy after primary sporozoite challenge and rechallenge, of GSK Biologicals’ candidate malaria vaccines containing the antigen RTS,S adjuvanted with either AS02A or AS01B and administered intramuscularly at months 0, 1, 2 in healthy malaria-naive volunteers aged 18 - 45 years Study Listed on ClinicalStudyDataRequest.com
257049/034 Completed A bridging study to evaluate the safety and immunogenicity of GSK Biologicals’ candidate vaccines RTS,S/AS02D (0.5 mL dose) and RTS,S/AS02A (0.25 mL dose) administered according to a 0, 1, 2 month vaccination schedule in children aged 3 to 5 years living in a malaria-endemic region of Mozambique.
26090/007 Completed A Double-Blind Placebo Controlled Study to Compare Paroxetine with Maprotiline in the Treatment of Depression Study Listed on ClinicalStudyDataRequest.com
263855/001 Completed Single-blind, randomised clinical study to assess and compare the immunogenicity and reactogenicity of the SB Biologicals dTpa, Pa and pa vaccines, and 2 commercial Td vaccines when administered as a booster dose to healthy adolescents, previously vaccinated with the DTP whole cell vaccine (DTPw)
263855/002 Completed Single-blind, clinical study of the immunogenicity and reactogenicity of SB Biologicals’ dTpa, pa vaccines and a Td vaccine, given as a booster dose to healthy adults, from the age of 18 years onwards
263855/004 Completed Randomised clinical study of the consistency of three lots of SB Biologicals dTpa vaccine in terms of immunogenicity and reactogenicity, and of the immunogenicity and reactogenicity of SB Biologicals pa vaccine and Lederle’s Td vaccine when administered as a booster dose to healthy adolescents (10-14 years old)
263855/012 Completed Single-blind clinical study of the immunogenicity and reactogenicity of GSK Biologicals dTpa, pa vaccines and a Tdvaccine, given as a booster dose to healthy adults, from the age of 18 years onwards
263855/014 Completed A phase III, double-blind, randomized, single vaccination study of SmithKline Beecham Biologicals’ reduced antigen content diphtheria-tetanus-acellular pertussis and combined diphtheria-tetanus-whole cell Bordetella pertussis vaccines in healthy children.
263855/017 Completed Open, five-year immunogenicity follow-up of subjects who previously received GSK Biologicals dTpa vaccine or GSKBiologicals pa vaccine and Lederles Td vaccine at 10 to 14 years of age in study 263855/004 (EXT: dTpa-004) Study Listed on ClinicalStudyDataRequest.com
263855/019 Completed Open, non-randomized, phase IV study to evaluate immunogenicity and safety of GSK Biologicals’ dTpa vaccine when administered as single dose to healthy adolescents in their 11th to 18th year of life who were not previously vaccinated against pertussis and have anti-PT antibody titers < 20 EL.U/ml  Study Listed on ClinicalStudyDataRequest.com
263855/020 Completed An open, phase III, single center study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ dTpa vaccine administered as a single-dose booster in healthy adults aged ≥ 18 years. Study Listed on ClinicalStudyDataRequest.com
263855/028 Completed Single-blind, randomized, phase IV clinical trial to compare the immunogenicity of GSK Biologicals’ dTpa vaccine (Boostrix™) and Aventis Pasteur MSD’s tetanus toxoid vaccine (Tetavax®), ten days after vaccination of healthy adults 18 years of age and older Study Listed on ClinicalStudyDataRequest.com

 

 

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GSK-sponsored clinical studies are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.
GSK-sponsored clinical trials are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.

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