Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD 0299685 15mg | Experimental |
| |
| PD 0299685 30mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD 0299685 at 15mg BID | Drug | 5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study |
|
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Mobile | Alabama | 36608 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32734597 | Derived | Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2. | |
| 22818144 | Derived | Nickel JC, Crossland A, Davis E, Haab F, Mills IW, Rovner E, Scholfield D, Crook T. Investigation of a Ca2+ channel alpha2delta ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial. J Urol. 2012 Sep;188(3):817-23. doi: 10.1016/j.juro.2012.05.010. Epub 2012 Jul 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PD 0299685 at 30mg BID | Drug | 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. |
|
| placebo for PD 0299685 | Drug | Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study |
|
| 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 |
| Goodyear |
| Arizona |
| 85395 |
| United States |
| Pfizer Investigational Site | Litchfield Park | Arizona | 85340 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85032 | United States |
| Pfizer Investigational Site | Glendora | California | 91741 | United States |
| Pfizer Investigational Site | San Diego | California | 92103 | United States |
| Pfizer Investigational Site | Farmington | Connecticut | 06032 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32804 | United States |
| Pfizer Investigational Site | Jeffersonville | Indiana | 47130 | United States |
| Pfizer Investigational Site | Shreveport | Louisiana | 71106 | United States |
| Pfizer Investigational Site | Brighton | Massachusetts | 02135 | United States |
| Pfizer Investigational Site | Watertown | Massachusetts | 02472 | United States |
| Pfizer Investigational Site | Garden City | New York | 11530 | United States |
| Pfizer Investigational Site | Poughkeepsie | New York | 12601 | United States |
| Pfizer Investigational Site | Burlington | North Carolina | 27215 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45212 | United States |
| Pfizer Investigational Site | West Chester | Ohio | 45069 | United States |
| Pfizer Investigational Site | Bethany | Oklahoma | 73008 | United States |
| Pfizer Investigational Site | State College | Pennsylvania | 16801 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29425 | United States |
| Pfizer Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37232 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99208 | United States |
| Pfizer Investigational Site | Victoria | British Columbia | V8V 3N1 | Canada |
| Pfizer Investigational Site | Barrie | Ontario | L4M 7G1 | Canada |
| Pfizer Investigational Site | Kingston | Ontario | K7L 2V7 | Canada |
| Pfizer Investigational Site | Kingston | Ontario | K7L 3J7 | Canada |
| Pfizer Investigational Site | Kitchener | Ontario | N2N 2B9 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M6A 3B5 | Canada |
| Pfizer Investigational Site | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Pfizer Investigational Site | Herlev | 2730 | Denmark |
| Pfizer Investigational Site | Helsinki | 00290 | Finland |
| Pfizer Investigational Site | Kouvola | 45200 | Finland |
| Pfizer Investigational Site | OYS | 90029 | Finland |
| Pfizer Investigational Site | Seinäjoki | 60220 | Finland |
| Pfizer Investigational Site | Tampere | 33521 | Finland |
| Pfizer Investigational Site | Lyon | 69437 | France |
| Pfizer Investigational Site | Nantes | 44093 | France |
| Pfizer Investigational Site | Nîmes | 30029 | France |
| Pfizer Investigational Site | Paris | 75020 | France |
| Pfizer Investigational Site | Rennes | 35033 | France |
| Pfizer Investigational Site | Strasbourg | 67091 | France |
| Pfizer Investigational Site | Homburg | 66424 | Germany |
| Pfizer Investigational Site | München | 81679 | Germany |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C494814 | BID protein, human |
Not provided
Not provided
Not provided