NCT00739739

An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Interstitial Cystitis
• Painful Bladder Syndrome

Interventions

Type	Name	Description
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
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.
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

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-08-22
• Last updated: 2011-03-28

Locations

44 sites across 6 countries: United States, Canada, Denmark, Finland, France, Germany