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

NCT00999518 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2021-08-03

Study results available
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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

Conditions

  • Cystitis, Interstitial

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-22
Primary Completion
2010-11-17
Completion
2011-01-21

Countries

  • United States
  • Belgium
  • Canada
  • Finland
  • Hong Kong
  • Japan
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00999518 on ClinicalTrials.gov