NCT00220402

Brief Summary

This trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (SPM 907) in subjects with overactive bladder syndrome. Subjects completing the 12 week treatment period of SP583 had the opportunity to participate if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which could be followed on an annual basis. Two primary efficacy variables will be assessed, which are observation and assessment of adverse events and duration on therapy. Secondary efficacy parameters included various parameters derived from micturition diaries and the evaluation of Quality of Life questionnaires (KHQ and ICIQ-SF). The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2004

Typical duration for phase_3

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

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

November 24, 2008

Status Verified

November 1, 2008

Enrollment Period

3 years

First QC Date

August 30, 2005

Last Update Submit

November 21, 2008

Conditions

Overactive Bladder Syndrome

Interventions

SPM 907DRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participated in SP583

You may not qualify if:

  • Failure to complete 12 week treatment with SPM 907

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schwarz

Monheim, Germany

Location

Study Officials

  • Axel Steinert

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 22, 2005

Study Start

July 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

November 24, 2008

Record last verified: 2008-11

Locations

DE(1)