Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overactive Bladder Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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SPM 907

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participated in SP583

Exclusion Criteria

* Failure to complete 12 week treatment with SPM 907

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Axel Steinert

Role: STUDY_DIRECTOR

UCB Pharma

Locations

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Schwarz

Monheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SP738

Identifier Type: -

Identifier Source: org_study_id