A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental Ability

Summary

The purpose is to compare solifenacin and oxybutynin with an inactive tablet and assess any potential effects on mental ability.

Timeline

Start

2010-04

Primary completion

2010-12

Completion

2010-12

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Solifenacin vs Placebo; p = 0.3771; Least Square Mean Difference -20.986 (95% CI -68.580 to 26.607); ANCOVA NCT01126424 ↗

paper Neither agent was associated with significant changes from baseline in any of the five standard, composite outcomes of cognitive function PMID 23332882 ↗

Publications

• Background Wright BM. A simple mechanical ataxia-meter. J Physiol. 1971 Oct;218 Suppl:27P-28P. No abstract available.
• Wagg A, Dale M, Tretter R, Stow B, Compion G. Randomised, multicentre, placebo-controlled, double-blind crossover study investigating the effect of solifenacin and oxybutynin in elderly people with mild cognitive impairment: the SENIOR study. Eur Urol. 2013 Jul;64(1):74-81. doi: 10.1016/j.eururo.2013.01.002. Epub 2013 Jan 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Oxybutynin	Small molecule	5 mg	—
Subject	Solifenacin	Small molecule	5 mg	—

Indications

No indication recorded.