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

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

Cystitis, Interstitial

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.

Tanezumab

Placebo

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).

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.

Worst 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 worst bladder pain due to IC/PBS over the past 24 hours on an 11-point NRS ranging from 0 = no bladder pain to 10 = worst possible bladder pain.

Participants answered: "Considering all the ways your bladder condition (IC/PBS) affects you, how are you doing today?" Participants responded on a 5-point scale where 1 = very good and 5 = very poor.

Participants were asked: "compared to when you began this trial, how would you rate your IC/PBS symptoms now?" Participants responded by using a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved.

The micturition frequency per 24 hours was calculated from the sum of voids divided by the diary period over which they were collected.

The nocturnal frequency per 24 hours was defined as the number of voids after going to bed and before getting up (the times of going to bed and getting up were recorded in the diary). The nocturnal micturition per 24 hours was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.

The micturition urgency frequency per 24 hours was calculated as the sum of urgency episodes (when participant had to rush to get to the bathroom to urinate) occurring during the diary period when this was measured, divided by the number of days over which they were recorded.

Participants completed 7-item questionnaire assessing their urge to urinate over the past 24 hours. The items were assessed on a 5-point response scale ranging from 0 (never) to 4 (always). Urge to urinate was calculated as the total of the 7 'urge' items with a minimum total score of 0 and a maximum total score of 28. Higher scores indicated greater symptom severity. An average was determined from the 3 days recorded in the 7-day diary period prior to each assessment time point.

Mean volume voided per micturition was calculated as the total urine volume voided during the diary period when this was measured over 1 day, divided by the number of voids (with non missing volumes) during that day.

The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI was rated on a 0-5 scale. The sum of the individual question ratings was the total score for the ICSI. Total scores ranged from 0 to 20, with higher scores indicating greater symptom severity and bother.

BPI-sf is a 7-item self-administered questionnaire to assess the pain severity and pain interference on daily functions. Pain Severity Index (PSI) is an average of Questions 2-5 which measured the severity of pain (worst, least, average, right now) over past 24-hours on an 11-point scale (0=no pain to 10=pain as bad as you can imagine). Pain Interference Index (PII) is an average of 7 pain interference items of Question 7 that measured the level of interference of pain on daily function (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) on an 11-point scale (0=did not interfere to 10=completely interfered). Pain Severity Index and Pain Interference Index total scores ranged from 0 to 10, where higher scores indicate greater pain or greater interference.

Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant's response is rated on a 5-point scale where 1=extremely dissatisfied (dissatisf), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied. Number of participants with each response is reported.

Participant global preference is assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment (T/T), preference and willingness to continue using study medication. Participant reported previous T/T under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery, and no T/T. Participant preference was assessed on a 5-point scale where, 1=No, I definitely prefer my prior T/T (Def Pref Prior), 2=I have a slight preference for my prior T/T (Slight Pref Prior T/T), 3=I have no preference either way (No preference), 4=I have a slight preference for the drug that I am receiving now (Slight Pref Current), 5=Yes, I definitely prefer the drug that I am receiving (Def Pref Current Drug) now. Number of participants under each of the categories is reported. For previous T/T, a single participant may be represented in more than 1 category.

Participant willingness to re-use study medication is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your chronic prostatitis?" Participants responded on 5-point scale where, 1=No, I definitely would not want to use the same drug again (definitely not want), 2=I might not want to use the same drug again (might not want), 3=I am not sure (not sure), 4=I might want to use the same drug again (might want), 5=Yes, I would definitely want to use the same drug again (definitely want).

EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

PBIC-QoL: 25-item questionnaire to assess impact of IC/PBS on health related quality of life over past 7 days. PBIC-QoL included 17 items (Items 2, 5, 8, 11, 14, 18, 20 and 21 did not form part of final instrument), of which 13 were divided into 3 dimensions: activity limitations (Items 1, 3, 4, 6, 7), impact on emotional wellbeing (Items 13, 15, 16, 17, 19), impact on sleep (Items 22, 23, 24). Four items: Item 9 (impact on going out with friends), Item 10 (impact on concentration), Item 12 (impact on eating and drinking), Item 25 (impact on sex life) were scored separately to dimension scores as single items. Items were scored from 4 'not at all' to 0 'extremely difficult' or 'a very great deal'. Eight items included a 'not applicable' response option. Dimension scores ranged from 0 to 4, higher score indicate better quality of life. Total score=sum of the dimension and single item scores, ranged from 0 to 28, higher score indicated better quality of life.

For inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.

In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.

In case of inadequate pain relief or worsening symptoms of IC/PBS, acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) could be taken as rescue medication.

Serum samples were analyzed for total NGF using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric method (IA/LC/MS/MS) method.

Alabama Orthopaedic Clinic

Coastal Clinical Research, Inc.

Canyon State Urology

Elite Clinical Studies, LLC

Urology Specialists, Ltd.

Central Arizona Urologists

Arizona Research Center

Precision Trials, LLC

Valley Radiologists (x-ray only)

Valley Urologic Associates

Scottsdale Medical Imaging

Radiology Limited (x-ray only)

Arizona Urologic Specialists

Access Medical Imaging

Urology Associates of Central California

Citrus Valley Medical Research Inc.

Atlantic Urology Medical Group

Institute for Advanced Urology

Tri Valley Urology Group

Valley Neurology

Liberty Pacific Medical Imaging

Boulder Medical Center, PC

Longmont Clinic, PC

Longmont Medical Research Network

Women's Health Specialty Care

Grove Hill Clinical Research

Urology Center of Grove Hill

Brian J. Hines, MD

Stamford Therapeutics Consortium

Diagnostic Imaging (radiology only)

Urology Associates of Dover

Visions Clinical Research

Jacksonville Center for Clinical Research

University Urologists

Specialists in Urology

Advanced Urology Associates

Excel Medical Imaging

Urology Specialists of West Florida

Advanced Imaging Center Incorporated

Ocala Urology Specialists

Renstar Medical Research

Gateway Radiology (x-rays only)

Pinellas Urology, Inc.

Advanced Research Institute Incorporated

Midtown Imaging

Atlanta Medical Research Institute, LLC

Northside Hospital Radiology Services (x-ray only)

Atlanta Center for Medical Research

MRI Imaging of Georgia

MRI Imaging Of Georgia

Georgia Urology

Deaconess Clinic Downtown Research Institute

Metropolitan Urology

Deaconess Clinic Gateway Health Center Research Institute

American Health Network (X-Ray only)

Urology of Indiana, LLC

The Iowa Clinic, Medical Imaging

The Iowa Clinic, Urology

Regional Urology, LLC

Anne Arundel Diagnostics Imaging

Anne Arundel Urology, PA

Alpha Clinical Research

Genesis Clinical Research and Consulting

Grand Rapids Women's Health dba Female Pelvic Medicine and Urogynecology Institute of Michigan

HealthCare Midwest

Rheumatology PC

Beyer Research

Beaumont Hospitals - Royal Oak

Michigan Institute of Urology, P.C.

CRL Imaging Southdale (x-rays only)

Medical Advanced Pain Specialists Applied Research Center Incorporated

Southeast Urology Network

Family Health Care Center (X-Ray)

Women's Clinic of Lincoln, P.C.

Capital Region Urological Surgeons

Benedictine Hospital

Hudson Valley Urology, PC

University Urology Associates

DRA Imaging, PC (X-Rays Only)

University of Rochester Medical Center

University of Rochester, Department of Urology

Crescent Medical Research

Salisbury Urological Clinic

Piedmont Medical Research

Tri-State Urologic Services PSC, Inc. dba The Urology Group

Central Ohio Urology Group

Columbus Urology Research, LLC

Premier Urology

Legacy Clinical Research, LLC

Planned Parenthood of Arkansas and Eastern Oklahoma

Oklahoma State University

Institute for Female Pelvic Medicine and Reconstructive Surgery

Urologic Consultants of Southeastern Pennsylvania

Jeanes Hospital

Matrix Research, LLC

The Urology Group

Bristol Urological Associates, PC

TriCities Medical Research

New Orleans Center for Clinical Research

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.

Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.

Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.

Tanezumab 1 mg

Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.

Tanezumab 2.5 mg

Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.

Tanezumab 10 mg

Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.

Tanezumab 20 mg

Total

Age, Continuous

Sex: Female, Male

Intent to treat (ITT) analysis set included all randomized participants who had received at least 1 dose of study medication.

The study was terminated due to lack of efficacy of all doses of tanezumab demonstrated during pre-planned interim analysis.

Pfizer ClinicalTrials.gov Call Center

The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% confidence interval (CI).

The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.

Baseline

Change at Week 8

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

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

Change at Week 1

Change at Week 2

Change at Week 3

Change at Week 4

Change at Week 5

Change at Week 6

Change at Week 7

Change at Week 9

Change at Week 10

Change at Week 11

Change at Week 12

Change at Week 13

Change at Week 14

Change at Week 15

Change at Week 16

Change at Week 17

Change at Week 18

Change at Week 19

Change at Week 20

Change at Week 21

Change at Week 22

Change at Week 23

Change at Week 24

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

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

Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.

Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.

Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.

Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.

Week 8: At least 30% Reduction

Week 8: At least 50% Reduction

Week 16: At least 30% Reduction

Week 16: At least 50% Reduction

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Missing values were imputed using baseline observation carried forward (BOCF) method.

Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score

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

Week 2

Week 8

Week 16

Week 24

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Patient Global Assessment of Health Status Scores

Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.

Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.

Week 8: Markedly Worse

Week 8: Moderately Worse

Week 8: Slightly Worse

Week 8: No Change

Week 8: Slightly Improved

Week 8: Moderately Improved

Week 8: Markedly Improved

Week 16: Markedly Worse

Week 16: Moderately Worse

ITT analysis set. Missing values were imputed using last observation carried forward (LOCF) method. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?