A LOCAL, MULTICENTRE, OPEN-LABEL, EXTENSION TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FESOTERODINE FLEXIBLE DOSE REGIMEN IN ELDERLY PATIENTS WITH OVERACTIVE BLADDER

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2010-018254-12-PT
• Date of registration: 08/02/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer, Inc
• Public title: A LOCAL, MULTICENTRE, OPEN-LABEL, EXTENSION TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FESOTERODINE FLEXIBLE DOSE REGIMEN IN ELDERLY PATIENTS WITH OVERACTIVE BLADDER
• Scientific title: A LOCAL, MULTICENTRE, OPEN-LABEL, EXTENSION TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FESOTERODINE FLEXIBLE DOSE REGIMEN IN ELDERLY PATIENTS WITH OVERACTIVE BLADDER
• Date of first enrolment: 16/03/2010
• Target sample size: 26
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018254-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Portugal

Key inclusion & exclusion criteria

Inclusion criteria:
1. Completed the A0221045 trial and has been recommended by the investigator for extended use of Fesoterodine

2. Able and willing to complete all the trial related questionnaires and comply with scheduled clinic visits and clinical trial procedures.

3. Capable of understanding and has signed the informed consent form after full discussion of the research nature of the treatment and its risk and benefits.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Any condition that would contraindicate their usage of Fesoterodine including: hypersensitivity to the active substance (Fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.

2. Predominant Stress Incontinence. Stress urinary incontinence as determined/estimated by the investigator.

3. Participated in any clinical trial other than A0221045 or received any other investigational drug within 4 weeks prior to enrollment Visit.

4. Other severe or acute medical condition (including newly diagnosed diabetes mellitus or newly diagnosed hypertension requiring treatment, or major hematological or cardiovascular conditions) or psychological condition or social circumstances that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of the study results or may impair ability to participate reliably in the trial, or may increase the risk to themselves or others as judged by the investigator.

5. Abuse of alcohol and/or any other drug in the opinion of the investigator.

6. Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Treatment of overactive bladder with symptoms of frequency, urgency, and urgency incontinence (Some patients will also have urgency urinary incontinence (UUI)).
MedDRA version: 9.1 Level: LLT Classification code 10059617 Term: Overactive bladder

Intervention(s)

Trade Name: Toviaz
Product Name: Fesoterodine
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Fesoterodine
CAS Number: 286930-03-8
Other descriptive name: Fesoterodine Fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-

Trade Name: Toviaz
Product Name: fesoterodine
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Fesoterodine
CAS Number: 286930-03-8
Other descriptive name: Fesoterodine Fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-

Primary Outcome(s)

Main Objective: To assess the long-term efficacy, in terms of maintenance of Fesoterodine effect on urgency episode frequency in elderly subjects with OAB.

Primary end point(s): • Mean number of micturition-related urgency episodes per 24h at end of treatment. Micturition-related urgency episodes are defined as those with Urinary Sensation Scale rating of =3 marked for the corresponding micturition in the diary.

Secondary Objective: • To assess the long-term safety and tolerability of Fesoterodine in elderly subjects with OAB.
• To assess the long-term efficacy, in terms of maintenance of Fesoterodine effect on other OAB symptoms, and on patient reported outcomes, in elderly subjects with OAB.

Secondary ID(s)

A0221090