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).
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).
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
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.
Inclusion Criteria:
Exclusion Criteria:
Grand Rapids, Michigan 49503, United States
Edina, Minnesota 55435, United States
Cofumbus, Ohio 43221, United States
Allentown, Pennsylvania 18103, United States
Barrie, Ontario L4M 7G1, Canada
Shatin, NEW Territories 0, Hong Kong
Arakawa-ku, Tokyo 116-8567, Japan
Bunkyo-ku, Tokyo 113-8655, Japan
Bialystok, 15-950, Poland
Moscow, 105425, Russia
Saint Petersburg, 198205, Russia
Saint Petersburg, filial 1 197022, Russia
Saint Petersburg, filial 1, 197022, Russia
Songpa-gu, Seoul 138-736, South Korea
Seoul, 135-710, South Korea
Koahsiung Hsien, 833, Taiwan