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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
161
5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
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.
Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study
Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
Time frame: 12 WEEKS
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
Time frame: 12 WEEKS
Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.
Time frame: 12 weeks
ICSI at other time points
Time frame: 12 weeks
Interstitial Cystitis Problem Index (ICPI)
Time frame: 12 weeks
Pelvic pain Urgency Frequency score (PUF)
Time frame: 12 weeks
Epworth Sleepiness Scale (ESS)
Time frame: 12 Weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 15 Weeks
Adverse events
Time frame: 15 Weeks
Physical examination
Time frame: 14 Weeks
Vital signs and weight
Time frame: 15 Weeks
ECG
Time frame: 14 Weeks
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Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Goodyear, Arizona, United States
Pfizer Investigational Site
Litchfield Park, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Glendora, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Farmington, Connecticut, United States
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
Jeffersonville, Indiana, United States
Pfizer Investigational Site
Shreveport, Louisiana, United States
...and 34 more locations
Residual urine volume measurement
Time frame: 14 Weeks
Global Response assessment (GRA)
Time frame: 12 Weeks
Patient Reported Treatment Impact (PRTI)
Time frame: 12 Weeks
Treatment failures
Time frame: 12 Weeks
Average and worst daily pain score at other time points as measured by an 11-point NRS.
Time frame: 12 Weeks
Sleep disturbance and sexual activity pain.
Time frame: 12 Weeks
Clinical laboratory tests
Time frame: 14 Weeks