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TERMINATEDPhase 2NCT00999518

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

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 effec...

Lead sponsor: Pfizer•122 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Pfizer

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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%.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 3, 2021Terms

Trial snapshot

StatusTERMINATED

PhasePHASE2

Enrollment205

Start dateJan 2010

Last updatedAug 3, 2021

Condition

Cystitis, Interstitial

Locations shown

Alabama Orthopaedic Clinic

Mobile, Alabama

Coastal Clinical Research, Inc.

Mobile, Alabama

Canyon State Urology

Glendale, Arizona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2021Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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