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).

Pfizer169 sites in 1 country205 target enrollmentJanuary 22, 2010

ConditionsCystitis, Interstitial

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cystitis, Interstitial
Sponsor: Pfizer
Enrollment: 205
Locations: 169
Primary Endpoint: Change From Baseline in Mean Average Daily Pain Score at Week 8
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 22, 2010

End Date

January 21, 2011

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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/m
•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%.

Outcomes

Primary Outcomes

Change From Baseline in Mean Average Daily Pain Score at Week 8

Time Frame: Baseline, Week 8

Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.

Secondary Outcomes

Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
Patient Global Assessment of Health Status Scores(Baseline, Week 2, 8, 16, 24)
Participant's Urge to Urinate(Baseline, Week 4, 8, 12, 16, 20, 24)
Brief Pain Inventory-Short Form (BPI-sf) Score(Baseline, Week 8, 16, 24)
Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score(Week 8, 16)
Number of Nocturnal Micturitions Per 24 Hours(Baseline, Week 4, 8, 12, 16, 20, 24)
Number of Micturition-related Urgency Episodes Per 24 Hours(Baseline, Week 4, 8, 12, 16, 20, 24)
Number of Participants With Patient Global Satisfaction Assessment Scores(Week 8, 16, 24)
Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score(Baseline, Week 2, 8, 16, 24)
Amount of Rescue Medication Taken Per Week(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
Number of Participants With Global Response Assessment Scores(Week 8, 16, 24)
Mean Voided Volume Per Micturition(Baseline, Week 4, 8, 12, 16, 20, 24)
Number of Participants With Patient Global Preference Assessment Score(Week 8, 16, 24)
Percentage of Participants Who Received Rescue Medication(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score(Baseline, Week 2, 8, 16, 24)
Number of Participants With Willingness to Re-use Medicine Assessment(Week 8, 16, 24)
Serum Total Nerve Growth Factor (NGF) Levels(Baseline, Week 1, 2, 8, 16, 24)
Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
Number of Micturitions Per 24 Hours(Baseline, Week 4, 8, 12, 16, 20, 24)
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score(Baseline, Week 8, 16, 24)
Number of Days of Rescue Medication Usage Per Week(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)
Number of Rescue Medication Doses Used Per Week(Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24)