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Sponsored by: |
Pfizer |
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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 |
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Interstitial Cystitis Painful Bladder Syndrome |
Drug: PD 0299685 at 15mg BID Drug: PD 0299685 at 30mg BID Drug: placebo for PD 0299685 |
Phase II |
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: | 147 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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
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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.
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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
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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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4291043 |
Study First Received: | August 20, 2008 |
Last Updated: | July 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00739739 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Cystitis, Interstitial Cystocele Urologic Diseases |
Urinary Bladder Diseases Cystitis Pain |
Cystitis, Interstitial Pathologic Processes Disease Urologic Diseases |
Syndrome Urinary Bladder Diseases Cystitis |