Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder

NCT01054222 | Completed Phase 4 Results

• 1 other identifier: A0221090
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open-label extension study intended for subjects who have previously completed study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the investigator as being suitable for the extended use of Fesoterodine. Data from this study will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older subjects from Portugal.

Conditions

Urinary Bladder, Overactive

Keywords

overactive bladder idiopathic; elderly fesoterodine SOFIA Portugal extension study

Outcome Measures

Primary Outcomes (1)

• Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT])

  The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with Urinary Sensation Scale (USS) rating of greater than or equal to (\>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.

  End of Treatment (up to Week 82)

Secondary Outcomes (15)

• Mean Number of Micturition-Related Urgency Episodes Per 24 Hours

  Baseline, Month 3, 6, 9, 12, 15, 18

• Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours

  Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

• Mean Number of Micturitions Per 24 Hours

  Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

• Mean Number of Nocturnal Micturitions Per 24 Hours

  Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

• Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours

  Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82)

Study Arms (2)

Fesoterodine 4 mg

OTHER

Dose determined as per previous drug regime in A0221045 and investigator's evaluation.

Drug: Fesoterodine

Fesoterodine 8 mg

OTHER

Dose determined as per previous drug regime in A0221045 and investigator's evaluation.

Drug: Fesoterodine

Interventions

Fesoterodine DRUG

Fesoterodine fumarate, sustained release (SR) tablet, 4 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier)

Also known as: Toviaz

Fesoterodine 4 mg

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects must have previously completed fesoterodine study A0221045 \[in Portugal\]

You may not qualify if:

• Conditions or states excluding use of fesoterodine e.g. contraindication to fesoterodine
• Predominant stress incontinence as determined by the investigator

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Centro de Avaliação Geriátrica

Lisbon, 1990-273, Portugal

Location

Hospital Ordem do Carmo

Porto, 4099-005, Portugal

Location

Hospital de São João

Porto, 4200-319, Portugal

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to the small sample size and that this is a single country study (Portugal) the results should be interpreted with caution.

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 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 22, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 15, 2013
• Results First Posted: May 15, 2013

Record last verified: 2013-02

Locations

PT (3)