Status:
TERMINATED
A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
Lead Sponsor:
Pfizer
Conditions:
Cystitis, Interstitial
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 effec...
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...
Eligibility Criteria
Inclusion
- 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
- 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%.
Key Trial Info
Start Date :
January 22 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2011
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00999518
Start Date
January 22 2010
End Date
January 21 2011
Last Update
August 3 2021
Active Locations (171)
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1
Alabama Orthopaedic Clinic
Mobile, Alabama, United States, 36608
2
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
3
Canyon State Urology
Glendale, Arizona, United States, 85306
4
Elite Clinical Studies, LLC
Phoenix, Arizona, United States, 85018