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A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

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).

NCT00999518•Pfizer

View on ClinicalTrials.gov

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

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day.
•Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped.

Exclusion Criteria

•Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome.
•Body mass index (BMI) of \>39 kg/m2.
•History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
•Patients with peripheral neuropathy.
•Patients with Type I or type II diabetes mellitus who have an HbA1c \> 8.0%.

Locations (171)

Alabama Orthopaedic Clinic

Mobile, Alabama, United States

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Canyon State Urology

Glendale, Arizona, United States

Elite Clinical Studies, LLC