Trials / Terminated
TerminatedNCT00999518
A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
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).
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 205 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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
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 following a pre-planned interim analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tanezumab | 1 mg dose given subcutaneously twice at an 8-week interval. |
| BIOLOGICAL | Tanezumab | 2.5 mg dose given subcutaneously twice at an 8-week interval. |
| BIOLOGICAL | Tanezumab | 10 mg dose given subcutaneously twice at an 8-week interval. |
| BIOLOGICAL | Tanezumab | 20 mg dose given subcutaneously twice at an 8-week interval. |
| OTHER | Placebo | Placebo dose given subcutaneously twice at an 8-week interval. |
Timeline
- Start date
- 2010-01-22
- Primary completion
- 2010-11-17
- Completion
- 2011-01-21
- First posted
- 2009-10-21
- Last updated
- 2021-08-03
- Results posted
- 2021-08-03
Locations
171 sites across 14 countries: United States, Belgium, Canada, Finland, Hong Kong, Japan, Poland, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan
Source: ClinicalTrials.gov record NCT00999518. Inclusion in this directory is not an endorsement.