Home
Clinical Trials
A Study To Investigate Tanezu...

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

Last Updated: 2021-08-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-22

Study Completion Date

2011-01-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis

NCT00739739

Interstitial Cystitis Painful Bladder Syndrome

COMPLETED PHASE2

Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome

NCT00919113

Interstitial Cystitis Painful Bladder Syndrome

COMPLETED PHASE2

Interstitial Cystitis

NCT00056251

Interstitial Cystitis

COMPLETED PHASE2

Efficacy and Safety of AQX-1125 in IC/BPS

NCT01882543

Interstitial Cystitis Bladder Pain Syndrome

COMPLETED PHASE2

A Study to Test if Fremanezumab Reduces Pain in Patients With Interstitial Cystitis-Bladder Pain Syndrome

NCT04447729

Interstitial Cystitis

WITHDRAWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cystitis, Interstitial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Group Type EXPERIMENTAL

Tanezumab

Intervention Type BIOLOGICAL

1 mg dose given subcutaneously twice at an 8-week interval.

Group 2

Group Type EXPERIMENTAL

Tanezumab

Intervention Type BIOLOGICAL

2.5 mg dose given subcutaneously twice at an 8-week interval.

Group 3

Group Type EXPERIMENTAL

Tanezumab

Intervention Type BIOLOGICAL

10 mg dose given subcutaneously twice at an 8-week interval.

Group 4

Group Type EXPERIMENTAL

Tanezumab

Intervention Type BIOLOGICAL

20 mg dose given subcutaneously twice at an 8-week interval.

Group 5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo dose given subcutaneously twice at an 8-week interval.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tanezumab

1 mg dose given subcutaneously twice at an 8-week interval.

Intervention Type BIOLOGICAL

Tanezumab

2.5 mg dose given subcutaneously twice at an 8-week interval.

Intervention Type BIOLOGICAL

Tanezumab

10 mg dose given subcutaneously twice at an 8-week interval.

Intervention Type BIOLOGICAL

Tanezumab

20 mg dose given subcutaneously twice at an 8-week interval.

Intervention Type BIOLOGICAL

Placebo

Placebo dose given subcutaneously twice at an 8-week interval.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alabama Orthopaedic Clinic

Mobile, Alabama, United States

Site Status

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Site Status