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Tolterodine & Pregabalin

Phase 2

Overactive Bladder | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Dec 21, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment188

FDA Designations

No designations recorded

Clinical trial landscape

Tolterodine & Pregabalin · 1 trial · 1 indication

Phase 2 1
NCT00746681Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive BladderOveractive Bladder
COMPLETED188 Analytics
PHASE2COMPLETED
Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder
Overactive BladderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in mean voided volume per micturition (from baseline).
4 weeks

Secondary Endpoints

Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).
4 Weeks
Percentage and absolute change in urgency episode frequency
4 Weeks
Mean severity of urgency episodes
4 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALTolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily
BACTIVE_COMPARATORTolterodine SR 4 mg once daily
CPLACEBO_COMPARATORPlacebo
DEXPERIMENTALTolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily
EEXPERIMENTALPregabalin 150 mg twice daily

Interventions

NameTypeDescription
Tolterodine & PregabalinDRUGTolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks
TolterodineDRUGTolterodine SR, Oral, 4 mg, once daily for 4 weeks
PlaceboDRUGPlacebo, Oral, twice daily for 4 weeks
PregabalinDRUGPregabalin, Oral, 150 mg twice daily for 4 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Women \> 18 years Old * Diagnosis of OAB (micturition frequency \>/= 8 times per day; urinary urgency \>/= 4 times per week) Exclusion Criteria: * Subjects with symptoms of overactive bladder for less than 6 months prior to randomization. * Significant stress incontinence as...

Countries:CzechiaLithuaniaNorwaySlovakiaSwedenUnited Kingdom
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Frequently asked questions about Tolterodine & Pregabalin

What is Tolterodine & Pregabalin used for?

Tolterodine & Pregabalin is an investigational combination of two small molecules being studied for the treatment of overactive bladder. It is in Phase 2 clinical development and is not approved by the FDA. The combination was evaluated in a completed clinical trial enrolling 188 female participants.

Who makes Tolterodine & Pregabalin?

Tolterodine & Pregabalin is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical research on this combination for overactive bladder, with the drug currently in Phase 2 development.

What phase is Tolterodine & Pregabalin in?

Tolterodine & Pregabalin is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial for the combination has been completed, with no active trials currently listed.

What clinical trials is Tolterodine & Pregabalin in?

Tolterodine & Pregabalin was studied in a completed Phase 2 trial, NCT00746681, titled 'Investigation of Tolterodine, Pregabalin and a Tolterodine - Pregabalin Combination for the Treatment of Overactive Bladder.' The trial enrolled 188 female participants aged 18 years and older across six European countries.

Is Tolterodine & Pregabalin the same as tolterodine or pregabalin alone?

Tolterodine & Pregabalin is a combination product containing both tolterodine and pregabalin, which are individual drugs. The Phase 2 trial NCT00746681 investigated the combination compared to each component alone and placebo, but the combination is a distinct investigational product.