NCT01042236

Brief Summary

The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 1, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

1.5 years

First QC Date

January 4, 2010

Results QC Date

June 8, 2011

Last Update Submit

July 20, 2011

Conditions

Stress Urinary Incontinence

Keywords

Phase 2 stress urinary incontinence Fesoterodine

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Opening Urethral Pressure (OUP) at Day 7

    OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.

    Baseline, Day 7 of each period

Secondary Outcomes (10)

  • Change From Baseline in Closing Urethral Pressure at Day 7

    Baseline, Day 7 of each period

  • Change From Baseline in Opening Urethral Elastance at Day 7

    Baseline, Day 7 of each period

  • Change From Baseline in Closing Urethral Elastance at Day 7

    Baseline, Day 7 of each period

  • Incontinence Episode Frequency Per 24 Hours

    Baseline, Day 7 of each period

  • Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours

    Baseline, Day 7 of each period

  • +5 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Fesoterodine

Interventions

FesoterodineDRUG

Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods

Also known as: Toviaz
Arm 1

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, 18 - 65 years
  • SUI symptoms for longer than 3 months
  • Subjects must be non-pregnant and not breastfeeding

You may not qualify if:

  • Disease or medical condition affecting the bladder or urinary tract (other tan stress urinary incontinence)
  • Subjects taking medication with effects on the bladder or urinary tract
  • Subejcts with medical conditions which could be adversely affected by administration of fesoterodine - gastrointestinal tract disease, glaucoma, hepatic impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

  • Klarskov N, Darekar A, Scholfield D, Whelan L, Lose G. Effect of fesoterodine on urethral closure function in women with stress urinary incontinence assessed by urethral pressure reflectometry. Int Urogynecol J. 2014 Jun;25(6):755-60. doi: 10.1007/s00192-013-2269-6. Epub 2013 Nov 21.

    PMID: 24258099DERIVED

Related Links

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

July 22, 2011

Results First Posted

July 1, 2011

Record last verified: 2011-07

Locations

DK(1)