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A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome

Cystitis, Interstitial Clinical Trial

Official title:
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS).

Clinical Trial Summary

In a previous study in patients with interstitial cystitis/ painful bladder syndrome (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS, as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab was well tolerated. In this study, the hypothesis being tested is that tanezumab will show efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety will also be assessed at different dose levels

Clinical Trial Description

This study was terminated on 16 November 2010 following a US FDA partial clinical hold for the tanezumab interstitial cystitis clinical study announced on 19 July 2010 for potential safety issues, and following a pre-planned interim analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00999518
Study type Interventional
Source Pfizer
Contact
Status Terminated
Phase Phase 2
Start date January 22, 2010
Completion date January 21, 2011
View Details
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