1,679
Participants
Start Date
May 12, 2016
Primary Completion Date
February 27, 2017
Study Completion Date
February 27, 2017
Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool
The BPE/BPO screening tool has been developed using the currently recommended Food and Drug Administration (FDA) 2009 guidelines for developing patient-completed questionnaires such as Patient Reported Outcomes. The tool to be used in this study in the General Practice setting has undergone validation in a urology setting to demonstrate the validity of the tool in populations with and without a definite diagnosis of BPH. Subjects who have a positive score on the BPE/BPO screening tool (total score \>=3) and meet all other eligibility requirements will be enrolled in Part I of the study.
International Prostate Symptom Score (IPSS) screening tool
The International Prostate Symptom Score (IPSS) score is a validated tool to assess the severity of LUTS symptoms, and has similarly been used for assessing symptomatic efficacy of treatments for BPH. Subjects who have a positive score on the IPSS tool (score \>=8) and meet all other eligibility requirements will be enrolled in Part I of the study.
GSK Investigational Site, Berlin
GSK Investigational Site, Cadiz
GSK Investigational Site, Granada
GSK Investigational Site, Rosiers-d'Égletons
GSK Investigational Site, Buchholz
GSK Investigational Site, Magdeburg
GSK Investigational Site, Seville
GSK Investigational Site, Bormujo (Sevilla)
GSK Investigational Site, Haute-Goulaine
GSK Investigational Site, Aigrefeuille-sur-Maine
GSK Investigational Site, Nantes
GSK Investigational Site, La Montagne
GSK Investigational Site, Valencia
GSK Investigational Site, Valencia
GSK Investigational Site, Civitella Paganico (GR)
GSK Investigational Site, Grosseto
GSK Investigational Site, Grenay
GSK Investigational Site, Flörsheim
GSK Investigational Site, Weinheim
GSK Investigational Site, Galatina (LE)
GSK Investigational Site, Cutrofiano (LE)
GSK Investigational Site, Aradeo
GSK Investigational Site, Ruffano (LE)
GSK Investigational Site, Rouen
GSK Investigational Site, Thouars
GSK Investigational Site, Munich
GSK Investigational Site, Moscow
GSK Investigational Site, Odintsovo
GSK Investigational Site, Naro-Fominsk
GSK Investigational Site, Yaroslavl
GSK Investigational Site, Ivanovo
GSK Investigational Site, Arkhangelsk
GSK Investigational Site, Saint Petesburg
GSK Investigational Site, Saint Petersburg
GSK Investigational Site, Saint Petersburg
GSK Investigational Site, St'Petersburg
GSK Investigational Site, Saint Petersburg
GSK Investigational Site, Smolensk
GSK Investigational Site, Izhevsk
GSK Investigational Site, Ulyanovsk
GSK Investigational Site, Novosibirsk
GSK Investigational Site, Dippoldiswalde
GSK Investigational Site, Freital
GSK Investigational Site, Leipzig
GSK Investigational Site, Tomsk
Lead Sponsor
GlaxoSmithKline
INDUSTRY