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Study ID Status Title Patient Level Data
548-01 Completed GG548 (naratriptan) Phase I study (single oral dose study in healthy male volunteers).
552002 Completed A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of a New Chemical Entity for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis
58 Completed A Double-Blind, Placebo-Controlled Trial of Bupropion SR for SSRI-Induced Sexual Dysfunction – Extensive searching has revealed that no clinical study report is available for this study. The clinical trial results were reported via publication; see citation below.
580299/001 Completed A double-blind, placebo-controlled, randomised study of the efficacy of an HPV-16/18 VLP vaccine in the prevention of HPV-16 and/or HPV-18 cervical infection in healthy adolescent and young adult women in North America and Brazil. Study Listed on ClinicalStudyDataRequest.com
580299/002 Completed A Phase I Study of the Safety and Immunogenicity of MEDI-517, a Vaccine Against Human Papillomavirus Types 16 and 18, in Healthy Adult Female Volunteers. Study Listed on ClinicalStudyDataRequest.com
580299/003 Completed A Phase I/II Study to evaluate the safety and immunogenicity of MEDI-517, a virus-like particle vaccine against human papillomavirus (HPV) types 16 and 18, in healthy adult female volunteers who are HPV-16 or HPV-18 DNA positive Study Listed on ClinicalStudyDataRequest.com
580299/004 Completed Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine against Human Papillomavirus Types 16 and 18, when Formulated with Aluminum Hydroxide, AS04, or without Adjuvant, in Healthy Adult Female Volunteers Study Listed on ClinicalStudyDataRequest.com
580299/005 Completed A Phase II Double-Blind, Randomized, Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, in Healthy Adult Female Volunteers Study Listed on ClinicalStudyDataRequest.com
580299/007 Completed Study of the efficacy of candidate HPV 16/18 VLP vaccine in the prevention of HPV-16 and/or HPV-18 cervical infection in adolescent & young adult women in North America and Brazil vaccinated in primary study 580299/001 Study Listed on ClinicalStudyDataRequest.com
580299/008 Completed A phase III, double-blind, randomized, controlled, multi-center study to evaluate the efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 vaccine compared to hepatitis A vaccine as control in prevention of persistent HPV-16 or HPV-18 cervical infection and cervical neoplasia, administered intramuscularly according to a 0, 1, 6 month schedule in healthy females 15-25 years of age. Study Listed on ClinicalStudyDataRequest.com
580299/009 Completed Study of the efficacy of an HPV16/18 VLP vaccine in the prevention of advanced cervical intraepithelial neoplasia (CIN2, CIN3, adenocarcinoma in situ and invasive cervical cancer) associated with HPV16 or HPV18 cervical infection in healthy young adult women in Costa Rica.
580299/011 Completed An observer-blind, randomized, controlled study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy male subjects aged 10-18 years Study Listed on ClinicalStudyDataRequest.com
580299/012 Completed Immunogenicity: 3 consecutive lots of GSK Biologicals’ HPV-16/18 vaccine administered intramuscularly at 0,1,6 month schedule in healthy females aged 10–25 years and demonstrate non-inferiority of candidate HPV vaccine manufactured by modified production process Study Listed on ClinicalStudyDataRequest.com
580299/013 Completed Evaluate the safety and immunogenicity of GSK Biologicals’ HPV-16/18 vaccine administered intramuscularly according to a 0,1,6 month schedule in healthy female subjects (10 – 14 years) Study Listed on ClinicalStudyDataRequest.com
63102 Completed A single, rising dose study of the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous Org31540/SR90107A in healthy male and female elderly volunteers
63103 Completed A repeated rising-dose, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous Org31540/SR90107A administered for 7 consecutive days to healthy male and female elderly volunteers
63105 Completed A study to evaluate safety, tolerability and pharmacokinetics of 2, 4, 6, 12, 16,18, and 20 mg of the pentasaccharide Org31540/SR90107A, administered as a single intravenous bolus injection to healthy elderly subjects
63106 Completed A four-period cross-over study to assess the absolute bioavailability, safety and tolerability of the pentasaccharide Org31540/SR90107A, after single dose subcutaneous administration of 2, 4 and 8 mg compared with 4 mg intravenous administration to healthy elderly subjects
63107 Completed Study to Assess the Safety/Tolerability and the Pharmacokinetics/Pharmacodynamics of Org31540/SR90107A Administered As A Single Intravenous Bolus Injection to Healthy Volunteers and Patients with Impaired Renal Function
63108 Completed An interaction study with subcutaneously administered Org31540/SR90107A and oral warfarin in healthy male volunteers (Protocol 63108)
63109_B Completed Interaction study with Org31540/SR90107A and piroxicam in healthy male volunteers
63113 Completed A randomized, assessor-blind, dose reducing, phase II study to assess the safety and efficacy of 10, 8, 6 and 4 mg Org31540/SR90107A and standard treatment with intravenous fragmin in patients with chronic intermittent haemodialysis
63118 Completed European Pentasaccharide Hip Elective Surgery Study (EPHESUS): A multicenter, randomized, double-blind comparison of once daily subcutaneous Org31540/SR90107A with enoxaparin for the prevention of deep vein thrombosis or symptomatic pulmonary embolism in patients undergoing elective hip replacem ...
63119 Completed A double blind, randomized, controlled, dose ranging study of Org31540/SR90107A in patients with unstable angina pectoris: PENTUA
63123 Completed A multicentre, randomized, open-label study comparing the efficacy and safety of once daily (o.d.) Org31540/SR90107A versus adjusted dose intravenous (i.v.) unfractionated heparin (UFH) in the initial treatment of acute symptomatic pulmonary embolism (PE) (MATISSE-PE)

 

 

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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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