Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder: a Double-Blind Phase Followed by an Open-Label Extension Phase

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

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2007-06-30

Brief Summary

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This extension trial of SP668 consists of two phases: double-blind treatment and open-label extension. The trial provides subjects the option of long-term treatment with sustained release (SR) fesoterodine (SPM 907) and to assess long-term subject safety, tolerability and efficacy.

Double-Blind: Subjects remained on either fesoterodine 4mg, 8mg or 12mg depending on their dose assignment in SP668. Previous SP668 placebo subjects received fesoterodine 4mg.

Open-Label: Subjects received fesoterodine 8mg with a one time option to reduce the dose to 4mg and a one time option to increase again to 8mg.

The primary variables focus on long-term safety and tolerability and include the observation and assessment of adverse events, residual urinary volumes, laboratory parameters, changes in ECG, physical and urological examinations and subject's assessment of treatment tolerance.

Secondary efficacy variables include various parameters derived from micturition diaries, count of subjects and their dose choice throughout the trial and subject's assessment of treatment efficacy.

Detailed Description

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Conditions

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Overactive Bladder

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

* Overactive bladder

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Brooke Derby

Role: STUDY_DIRECTOR

UCB Pharma

Locations

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Schwarz

RTP, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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SP669

Identifier Type: -

Identifier Source: org_study_id