An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.

Official Title
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A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.

Conditions
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Interstitial Cystitis, Painful Bladder Syndrome

Intervention / Treatment
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* Drug: PD 0299685 at 15mg BID
* Drug: PD 0299685 at 30mg BID
* Drug: placebo for PD 0299685


Participation Criteria
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Eligibility Criteria
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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: History of interstitial cystitis less than 6 months History of current or recurrent urinary tract infections, or genitourinary cancer Any previous urinary diversion procedure with or without bladder removal, bladder augmentation Use of certain drugs given into the bladder up to 1 month prior to study entry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PD 0299685 15mg<br> | Drug: PD 0299685 at 15mg BID<br>* 5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study<br>|
| Experimental: PD 0299685 30mg<br> | Drug: PD 0299685 at 30mg BID<br>* 10mg 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo for PD 0299685<br>* Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pelvic pain Urgency Frequency score (PUF) |  | 12 weeks | 
| Epworth Sleepiness Scale (ESS) |  | 12 Weeks | 
| Columbia-Suicide Severity Rating Scale (C-SSRS) |  | 15 Weeks | 
| Adverse events |  | 15 Weeks | 
| Physical examination |  | 14 Weeks | 
| Vital signs and weight |  | 15 Weeks | 
| ECG |  | 14 Weeks | 
| Residual urine volume measurement |  | 14 Weeks | 
| Global Response assessment (GRA) |  | 12 Weeks | 
| Patient Reported Treatment Impact (PRTI) |  | 12 Weeks | 
| Treatment failures |  | 12 Weeks | 
| Average and worst daily pain score at other time points as measured by an 11-point NRS. |  | 12 Weeks | 
| Sleep disturbance and sexual activity pain. |  | 12 Weeks | 
| Clinical laboratory tests |  | 14 Weeks |