UK Study Assessing Flexible Dose Fesoterodine in Adults

NCT00806494 | Completed Phase 4 Results

• 1 other identifier: A0221058
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 39

Brief Summary

To explore the effects of fesoterodine when used in a flexible dose manner

Conditions

Urinary Bladder, Overactive

Keywords

Fesoterodine; Open Label; Flexible Dose; OAB

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12

  The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.

  Baseline, Week 12

Secondary Outcomes (20)

• Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4

  Baseline, Week 4

• Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12

  Baseline, Week 4 and Week 12

• Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12

  Baseline, Week 4 and Week 12

• Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12

  Baseline, Week 4 and Week 12

• Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12

  Baseline, Week 4 and Week 12

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Fesoterodine 4mg, escalating to 8mg as required

Drug: Fesoterodine

Interventions

Fesoterodine DRUG

Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \>18 years old
• OAB for \>3 months

You may not qualify if:

• Patients with conditions that would contraindicate for fesoterodine use
• Patients with significant hepatic and renal disease or other significant unstable diseases.
• OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (39)

Pfizer Investigational Site

Ely, Cambridgeshire, CB7 5JD, United Kingdom

Location

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Crewe, Cheshire, CW1 4QJ, United Kingdom

Location

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Fowey, Cornwall, PL23 1DT, United Kingdom

Location

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Penzance, Cornwall, TR18 4JH, United Kingdom

Location

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Chesterfield, Derbyshire, S40 4TF, United Kingdom

Location

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Chesterfield, Derbyshire, S44 5BL, United Kingdom

Location

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Plymouth, Devon, PL5 3JB, United Kingdom

Location

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Bexhill-on-Sea, East Sussex, TN40 1JJ, United Kingdom

Location

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Baillieston, Glasgow, G69 7AD, United Kingdom

Location

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Blackpool, Lancashire, FY3 7EN, United Kingdom

Location

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Blackpool, Lancashire, FY4 3AD, United Kingdom

Location

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Hinckley, Leicestershire, LE10 2SE, United Kingdom

Location

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West Didsbury, Manchester, M20 2LR, United Kingdom

Location

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Ashford, Middlesex, TW15 3EA, United Kingdom

Location

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Northwood, Middlesex, HA6 2RN, United Kingdom

Location

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Mortimer, Reading, RG7 2BH, United Kingdom

Location

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Ayrshire, Scotland, KA12 0AY, United Kingdom

Location

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Falkirk, Scotland, FK1 5QE, United Kingdom

Location

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Winterton, Scunthorpe, DN15 9TA, United Kingdom

Location

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Bath, Somerset, BA1 2SR, United Kingdom

Location

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Doncaster, South Yorkshire, DN9 1ND, United Kingdom

Location

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Sheffield, South Yorkshire, S7 2DW, United Kingdom

Location

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Addlestone, Surrey, KT15 2BH, United Kingdom

Location

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Leatherhead, Surrey, KT24 6QT, United Kingdom

Location

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Worthing, West Sussex, BN11 2DH, United Kingdom

Location

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Bradford-on-Avon, Wiltshire, BA1 5DQ, United Kingdom

Location

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Chippenham, Wilts, SN14 8GT, United Kingdom

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Bath, BA2 3HT, United Kingdom

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Bath, BA2 4BY, United Kingdom

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Bristol, BS2 8HW, United Kingdom

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Bucks, HP22 5LB, United Kingdom

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Glasgow, G51 4TF, United Kingdom

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Hertfordshire, WD25 0EA, United Kingdom

Location

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London, SE5 9RS, United Kingdom

Location

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London, W1P 9LL, United Kingdom

Location

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Northants, NN8 4RW, United Kingdom

Location

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Plymouth, PL6 8DH, United Kingdom

Location

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Swansea, SA6 6NL, United Kingdom

Location

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Swindon, SN25 4YZ, United Kingdom

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

This was a single arm, non-comparative study. Hence no formal hypothesis testing was performed, and assessment of efficacy was based on changes from baseline in efficacy endpoints.

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: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: February 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 26, 2011
• Results First Posted: January 26, 2011

Record last verified: 2011-01

Locations

GB (39)