A 5-way Treatment Period Trial of Single Doses of Intranasal GSK256066 in Patients With Rhinitis

Summary

This current study is planned as a dedicated pharmacodynamic (effect of drug on the body) study to investigate the dose response in rhinitic subjects at doses where GSK256066 has been proven to work (200mcg) or expected to (50mcg) work. This study also aims to investigate the lower end of the predicted therapeutic range.

Timeline

Start

2007-03-28

Primary completion

2007-05-16

Completion

2007-05-16

Outcome

Mixed primary results

registry Placebo vs GSK256066 10 mcg; p = 0.0383; Treatment Ratios 1.19 (95% CI 1.01 to 1.41); ANOVA NCT00464568 ↗

registry Placebo vs GSK256066 1 mcg; p = 0.8718; Treatment Ratios 1.03 (95% CI 0.74 to 1.43); ANOVA NCT00464568 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GSK256066	Small molecule	50 ug	Intranasal
Subject	GSK256066	Small molecule	200 ug	Intranasal

Indications