A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
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Study type
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Details and patient eligibility
About
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
Full 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.
Enrollment
Sex
Ages
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%.
Trial design
Primary purpose
Allocation
Interventional model
Masking
205 participants in 5 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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