Interstitial Cystitis, Painful Bladder Syndrome
Conditions
Brief summary
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.
Interventions
DRUGPD 0299685 at 15mg BID
5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
DRUGPD 0299685 at 30mg BID
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.
DRUGplacebo for PD 0299685
Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes. | 12 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 |
| ECG | 14 Weeks |
| ICSI at other time points | 12 weeks |
Countries
Canada, Denmark, Finland, France, Germany, United States
Outcome results
None listed