|
|
|
|
|
|
Sponsored by: |
Pfizer |
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00739739 |
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.
Condition | Intervention | Phase |
Interstitial Cystitis Painful Bladder Syndrome |
Drug: PD 0299685 at 15mg BID Drug: placebo for PD 0299685 Drug: PD 0299685 at 30mg BID |
Phase II |
MedlinePlus related topics: | Interstitial Cystitis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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. |
Estimated Enrollment: | 129 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
PD 0299685 15mg: Experimental |
Drug: PD 0299685 at 15mg BID
5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
|
PD 0299685 30mg: Experimental |
Drug: PD 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.
|
Placebo: Placebo Comparator |
Drug: placebo 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
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, Alabama | |||||
Pfizer Investigational Site | Not yet recruiting | ||||
Mobile, Alabama, United States, 36608 | |||||
United States, California | |||||
Pfizer Investigational Site | Recruiting | ||||
Glendora, California, United States, 91741 | |||||
United States, New York | |||||
Pfizer Investigational Site | Recruiting | ||||
Poughkeepsie, New York, United States, 12601 | |||||
Pfizer Investigational Site | Recruiting | ||||
Garden City, New York, United States, 11530 | |||||
United States, North Carolina | |||||
Pfizer Investigational Site | Not yet recruiting | ||||
Burlington, North Carolina, United States, 27215 | |||||
United States, Ohio | |||||
Pfizer Investigational Site | Not yet recruiting | ||||
West Chester, Ohio, United States, 45069 | |||||
United States, Pennsylvania | |||||
Pfizer Investigational Site | Not yet recruiting | ||||
State College, Pennsylvania, United States, 16801 | |||||
Canada, Ontario | |||||
Pfizer Investigational Site | Not yet recruiting | ||||
Barrie, Ontario, Canada, L4M 7G1 | |||||
Pfizer Investigational Site | Not yet recruiting | ||||
Toronto, Ontario, Canada, M6A 3B5 |
Pfizer |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
To obtain contact information for a study center near you, click here. 
  |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4291043 |
First Received: | August 20, 2008 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00739739 |
Health Authority: | United States: Food and Drug Administration |
|
|