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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Cystitis, Interstitial

In brief

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

Key facts

Study ID

NCT00999518

Run by

Pfizer

People needed

205

Starts

2010-01-22

Expected to finish

2011-01-21

Last updated by the study team

2021-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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%.

Where it is running

• Coastal Clinical Research, Inc. — Mobile, Alabama, United States
• Canyon State Urology — Glendale, Arizona, United States
• Elite Clinical Studies, LLC — Phoenix, Arizona, United States
• Urology Specialists, Ltd. — Phoenix, Arizona, United States
• Central Arizona Urologists — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Precision Trials, LLC — Phoenix, Arizona, United States
• Valley Radiologists (x-ray only) — Phoenix, Arizona, United States
• Valley Urologic Associates — Phoenix, Arizona, United States
• Scottsdale Medical Imaging — Scottsdale, Arizona, United States
• Radiology Limited (x-ray only) — Tucson, Arizona, United States
• Arizona Urologic Specialists — Tucson, Arizona, United States
• Access Medical Imaging — Beverly Hills, California, United States
• Urology Associates of Central California — Fresno, California, United States
• Citrus Valley Medical Research Inc. — Glendora, California, United States
• Atlantic Urology Medical Group — Long Beach, California, United States
• Institute for Advanced Urology — Los Angeles, California, United States
• Tri Valley Urology Group — Murrieta, California, United States
• Valley Neurology — Murrieta, California, United States
• Liberty Pacific Medical Imaging — Signal Hill, California, United States
• Boulder Medical Center, PC — Boulder, Colorado, United States
• Longmont Clinic, PC — Longmont, Colorado, United States
• Longmont Medical Research Network — Longmont, Colorado, United States
• Women's Health Specialty Care — Farmington, Connecticut, United States
• Alabama Orthopaedic Clinic — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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