Trials Sponsors Conditions Drugs Pricing

Conditions

Overactive Bladder Mild Cognitive Impairment

Keywords

crossover studyplacebo controlleddouble blindoveractive bladder

Outcome Measures

Primary Outcomes (1)

continuity of attention
Continuity of Attention: Accuracy of responding in Choice Reaction Time task Percent Target Detection in Digit Vigilance task False Alarms in Digit Vigilance task
1 and 4h post dose

Secondary Outcomes (1)

cognitive function
1 and 4h post last dose of study drug

Study Arms (4)

Fesoterodine 4mg daily

EXPERIMENTAL

fesoterodine 4mg oral

Drug: fesoterodine 4mgDrug: OxybutyninDrug: placeboDrug: fesoterodine 8mg

Fesoterodine 8mg

EXPERIMENTAL

Fesoterodine 8mg in form of 2, 4mg tablets

Drug: fesoterodine 4mgDrug: OxybutyninDrug: placeboDrug: fesoterodine 8mg

Interventions

fesoterodine 4mgDrug

7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning

Also known as: Toviaz

Fesoterodine 4mg dailyFesoterodine 8mgoxybutyninplacebo capsule

OxybutyninDrug

Eligibility Criteria

Age75 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

The subject is either male or female and ≥ 75 years of age.
The subject has OAB as determined by ICS criteria

Sponsors & Collaborators

Pfizer
Industrycollaborator
University of Alberta
Otherlead

Study Sites (1)

Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp

Edmonton, Alberta, T6G 2P4, Canada

Related Publications (3)

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.
PMID: 23332882BACKGROUND
Wesnes KA, Edgar C, Tretter RN, Bolodeoku J. Exploratory pilot study assessing the risk of cognitive impairment or sedation in the elderly following single doses of solifenacin 10 mg. Expert Opin Drug Saf. 2009 Nov;8(6):615-26. doi: 10.1517/14740330903260790.
PMID: 19747069BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, OveractiveCognitive Dysfunction

Interventions

fesoterodineoxybutynin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Adrian S Wagg, MD
University of Alberta
PRINCIPAL INVESTIGATOR

Enrollment

47 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Research Chair in Healthy Aging

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 15, 2014

Study Start

August 2016

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

The subject does not have OAB.
The subject has either dementia or moderate to severe cognitive impairment at screening.
The subject has probable clinical depression as determined by Geriatric Depression Scale (GDS) short form \>5 at screening.
Subjects taking any cognitive enhancers (cholinesterase inhibitors or memantine).
The subject has a history of allergy to the study drug(s), to any component of the dosage form or any other allergy, which, in the opinion of the Investigator, contraindicates their participation.
The subject has any clinically significant abnormal heart rate or blood pressure measurements, at the screening visit, which, in the opinion of the Investigator, prevent safe participation in the study. (dBP\< 60mmHg or \> 90mmHg, sBP \< 95mmHg or \> 160mmHg or HR \< 40bpm or \> 100bpm).
Subjects with known history of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony) or severe gastrointestinal conditions (including toxic megacolon or ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow interior chamber or subjects deemed to be at risk for these conditions.
Subjects undergoing haemodialysis or who have severe renal impairment.
Subjects with severe hepatic impairment, defined as Child-Pugh grade IV.
Subjects taking potent CYP 3A4 inhibitors which would, under normal circumstances, require adjustment of the dose of the test drugs.
Subject has taken prescribed medication within 14 days prior to the first study day or over-the-counter medicine (including vitamins and herbal remedies) within 48 hours prior to the first study day, which in the opinion of the Investigator, will interfere with the study procedures or compromise safety.
Subject has an average weekly alcohol intake of greater than 21 units (male) or 14 units (female) within the 90 days prior to the study. 1 unit is 270cc of beer, 40cc of spirits or 125cc of wine.
History of smoking more than 10 cigarettes (or the equivalent amount of tobacco) per day within the 90 days prior to the study.
Subject has participated in any clinical study within the last 90 days.
Any clinically significant abnormality following Investigator review of the pre study physical examination.
+2 more criteria

A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Fesoterodine 4mg daily

Fesoterodine 8mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

oxybutynin

placebo capsule

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Fesoterodine 4mg daily

Fesoterodine 8mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

oxybutynin

placebo capsule

You may not qualify if:

Source record

Locations