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SS-RBX

Phase 2

Urinary Incontinence, Stress | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Jun 1, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment420

FDA Designations

No designations recorded

Clinical trial landscape

SS-RBX · 2 trials · 1 indication

Phase 2 2
NCT00141128Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.Urinary Incontinence, Stress
COMPLETED18 Analytics
NCT00138749An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.Urinary Incontinence, Stress
COMPLETED402 Analytics
PHASE2COMPLETED
Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.
Urinary Incontinence, Stress
NCT0014112818
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PHASE2COMPLETED
An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.
Urinary Incontinence, Stress
NCT00138749402
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Study Endpoints

Primary Endpoints

To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra.
Proof of concept study to assess the efficacy, tolerability and safety of SS-RBX vs. placebo in the treatment of SUI.

Secondary Endpoints

To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI.
To evaluate whether an upward dose adjustment affects the tolerability of SS-RBX.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
SS-RBXDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Female * Stress urinary incontinence Exclusion Criteria: * Bladder outflow obstruction * Neurological disease

Countries:DenmarkUnited StatesCanada
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Frequently asked questions about SS-RBX

What is SS-RBX used for?

SS-RBX is an investigational small molecule being developed by Pfizer, Inc. for the treatment of stress urinary incontinence in women. It is currently in Phase 2 clinical development, and it has been studied in clinical trials for this condition.

Who makes SS-RBX?

SS-RBX is being developed by Pfizer, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in Phase 2 clinical development for stress urinary incontinence.

What phase is SS-RBX in?

SS-RBX is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 2 clinical trials have been completed, but the drug remains under investigation for stress urinary incontinence.

What clinical trials is SS-RBX in?

SS-RBX has been studied in two completed Phase 2 clinical trials. NCT00138749 was an 8-week study of efficacy, toleration, and safety in 402 women with stress urinary incontinence in the United States and Canada. NCT00141128 evaluated a novel methodology in assessing urethral function in 18 women in Denmark.

Is SS-RBX FDA approved?

SS-RBX is not FDA approved. It is an investigational drug in Phase 2 clinical development for stress urinary incontinence. Two Phase 2 trials have been completed, but the drug has not yet received regulatory approval.