Kusajili – Centralise les essais cliniques mondiaux

An Eight- Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of oral Solabegron (GW427353) 125mg and 50mg Administered Twice Daily vs Placebo in Women with Overactive Bladder The primary objective of this study is to compare the efficacy of solabegron 125mg and 50mg administered twice daily, to that of placebo in female subjects with OAB including symptoms of urgency with urge incontinence and frequency which may be associated with nocturia, but without bladder related pain.

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Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Centre, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD via nasal Biopsy in Subjects ≥18 Years of Age with Perennial Allergic Rhinitis (PAR) The primary objective of this study is to determine effects to the nasal mucosa of PAR subjects after one year of continuous treatment with GW685698X aqueous nasal spray 100mcg QD compared to a mometasone furoate aqueous nasal spray (Nasonex®) 200mcg QD reference control group as determined by blinded morphological and immunocytochemical analyses of nasal biopsy specimens. A separate healthy (nonallergic) control group of approximately 25 subjects will not receive any treatment, but will undergo a nasal biopsy at baseline and after 12 months to assess biopsy sampling technique artifact and monitor the influence of environmental factors over 12 months. ICST assessments of mucociliary clearance will also be conducted in subjects at one selected investigational site to determine the effects, if any, of treatment on ciliary function.

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