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PD 0299685 at

Phase 2

Interstitial Cystitis | Small molecule | Urology |Pfizer, Inc.|Last Updated: Mar 28, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment161

FDA Designations

No designations recorded

Clinical trial landscape

PD 0299685 at · 1 trial · 2 indications

Phase 2 1
NCT00739739An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial CystitisInterstitial Cystitis
COMPLETED161 Analytics
PHASE2COMPLETED
An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis
Interstitial CystitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
12 WEEKS
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
12 WEEKS

Secondary Endpoints

Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.
12 weeks
ICSI at other time points
12 weeks
Interstitial Cystitis Problem Index (ICPI)
12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PD 0299685 15mgEXPERIMENTAL -
PD 0299685 30mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PD 0299685 at 15mg BIDDRUG5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
PD 0299685 at 30mg BIDDRUG10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID.
placebo for PD 0299685DRUGCapsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Men and women over 18 years of age with moderate to severe interstitial cystitis defined by pain score. * Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception. Exclusion Criteria: * Histor...

Countries:United StatesCanadaDenmarkFinlandFranceGermany
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Frequently asked questions about PD 0299685 at

What is PD 0299685 used for?

PD 0299685 is an investigational small molecule being studied for the treatment of symptoms associated with interstitial cystitis, also known as painful bladder syndrome. It is being developed by Pfizer, Inc. as a potential therapy for this urological condition.

How does PD 0299685 work?

The specific molecular target of PD 0299685 has not been disclosed in available information. It is a small molecule being investigated for its potential to treat symptoms of interstitial cystitis, but its mechanism of action has not been publicly detailed.

Who makes PD 0299685?

PD 0299685 is being developed by Pfizer, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this compound for interstitial cystitis.

What phase is PD 0299685 in?

PD 0299685 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and effectiveness for interstitial cystitis.

What clinical trials is PD 0299685 in?

PD 0299685 has one completed Phase 2 clinical trial registered as NCT00739739. This randomized, double-blind, placebo-controlled study enrolled 161 participants with interstitial cystitis and painful bladder syndrome across the United States, Canada, Denmark, Finland, France, and Germany.

Is PD 0299685 the same as any other drug?

No alternative names for PD 0299685 have been disclosed in available information. It is identified solely by its development code PD 0299685 in clinical trial records and company communications.