Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit

Summary

To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.

Timeline

Start

2009-04

Primary completion

2009-12

Completion

2009-12

Outcome

Missed primary endpoint

Stopped: “Protocol A0221057 was terminated on December 25, 2009 for futility. There were no safety concerns related to this decision.”

registry analysis (superiority or other test); Fesoterodine vs Solifenacin; LS Mean difference 0.051 (95% CI -0.334 to 0.436); ANCOVA NCT00832650 ↗

Publications

• Bharucha AE, Isowa H, Hiro S, Guan Z. Differential effects of selective and non-selective muscarinic antagonists on gastrointestinal transit and bowel function in healthy women. Neurogastroenterol Motil. 2013 Jan;25(1):e35-43. doi: 10.1111/nmo.12043. Epub 2012 Nov 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fesoterodine	Other / unclassified	8 mg	—
Comparator	Solifenacin	Small molecule	10 mg	—

Indications

No indication recorded.