Study Stopped
See termination reason in detailed description.
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).
2 other identifiers
interventional
205
14 countries
171
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2010
Shorter than P25 for phase_2
171 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2009
CompletedFirst Posted
Study publicly available on registry
October 21, 2009
CompletedStudy Start
First participant enrolled
January 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2011
CompletedResults Posted
Study results publicly available
August 3, 2021
CompletedAugust 3, 2021
July 1, 2021
10 months
October 20, 2009
July 12, 2021
July 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean Average Daily Pain Score at 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.
Baseline, Week 8
Secondary Outcomes (22)
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
Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score
Week 8, 16
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
Patient Global Assessment of Health Status Scores
Baseline, Week 2, 8, 16, 24
Number of Participants With Global Response Assessment Scores
Week 8, 16, 24
- +17 more secondary outcomes
Other Outcomes (13)
Number of Participants With Neurological Examination Findings
Week 2, 8, 16, Week 24 or early termination
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24
Baseline, Week 2, 8, 16, 24
Body Temperature
Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
- +10 more other outcomes
Study Arms (5)
Group 1
EXPERIMENTALGroup 2
EXPERIMENTALGroup 3
EXPERIMENTALGroup 4
EXPERIMENTALGroup 5
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (171)
Alabama Orthopaedic Clinic
Mobile, Alabama, 36608, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Canyon State Urology
Glendale, Arizona, 85306, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, 85018, United States
Urology Specialists, Ltd.
Phoenix, Arizona, 85020, United States
Central Arizona Urologists
Phoenix, Arizona, 85021, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Precision Trials, LLC
Phoenix, Arizona, 85032, United States
Valley Radiologists (x-ray only)
Phoenix, Arizona, 85032, United States
Valley Urologic Associates
Phoenix, Arizona, 85032, United States
Scottsdale Medical Imaging
Scottsdale, Arizona, 85251, United States
Radiology Limited (x-ray only)
Tucson, Arizona, 85711, United States
Arizona Urologic Specialists
Tucson, Arizona, 85712, United States
Access Medical Imaging
Beverly Hills, California, 90211, United States
Urology Associates of Central California
Fresno, California, 93720, United States
Citrus Valley Medical Research Inc.
Glendora, California, 91741, United States
Atlantic Urology Medical Group
Long Beach, California, 90806, United States
Institute for Advanced Urology
Los Angeles, California, 90048, United States
Tri Valley Urology Group
Murrieta, California, 92562, United States
Valley Neurology
Murrieta, California, 92562, United States
Liberty Pacific Medical Imaging
Signal Hill, California, 90755, United States
Boulder Medical Center, PC
Boulder, Colorado, 80304, United States
Longmont Clinic, PC
Longmont, Colorado, 80501, United States
Longmont Medical Research Network
Longmont, Colorado, 80501, United States
Women's Health Specialty Care
Farmington, Connecticut, 06032, United States
Grove Hill Clinical Research
New Britain, Connecticut, 06052, United States
Urology Center of Grove Hill
New Britain, Connecticut, 06052, United States
Brian J. Hines, MD
Stamford, Connecticut, 06902, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Diagnostic Imaging (radiology only)
Dover, Delaware, 19901, United States
Urology Associates of Dover
Dover, Delaware, 19904, United States
Visions Clinical Research
Boynton Beach, Florida, 33472, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
University Urologists
Lake Worth, Florida, 33461, United States
Specialists in Urology
Naples, Florida, 34102, United States
Advanced Urology Associates
New Port Richey, Florida, 34652, United States
Excel Medical Imaging
New Port Richey, Florida, 34652, United States
Urology Specialists of West Florida
New Port Richey, Florida, 34655, United States
Advanced Imaging Center Incorporated
Ocala, Florida, 34471, United States
Ocala Urology Specialists
Ocala, Florida, 34471, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Gateway Radiology (x-rays only)
Pinellas Park, Florida, 33781, United States
Pinellas Urology, Inc.
St. Petersburg, Florida, 33710, United States
Advanced Research Institute Incorporated
Trinity, Florida, 34655, United States
Midtown Imaging
West Palm Beach, Florida, 33417, United States
Atlanta Medical Research Institute, LLC
Alpharetta, Georgia, 30005, United States
Northside Hospital Radiology Services (x-ray only)
Alpharetta, Georgia, 30005, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
MRI Imaging of Georgia
Atlanta, Georgia, 30308, United States
MRI Imaging Of Georgia
Atlanta, Georgia, 30327, United States
Georgia Urology
Decatur, Georgia, 30033, United States
Deaconess Clinic Downtown Research Institute
Evansville, Indiana, 47713, United States
Metropolitan Urology
Jeffersonville, Indiana, 47130, United States
Deaconess Clinic Gateway Health Center Research Institute
Newburgh, Indiana, 47630, United States
American Health Network (X-Ray only)
Noblesville, Indiana, 46062, United States
Urology of Indiana, LLC
Noblesville, Indiana, 46062, United States
The Iowa Clinic, Medical Imaging
West Des Moines, Iowa, 50266, United States
The Iowa Clinic, Urology
West Des Moines, Iowa, 50266, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Anne Arundel Diagnostics Imaging
Annapolis, Maryland, 21401, United States
Anne Arundel Urology, PA
Annapolis, Maryland, 21401, United States
Alpha Clinical Research
Brighton, Massachusetts, 02135, United States
Genesis Clinical Research and Consulting
Fall River, Massachusetts, 02720, United States
Grand Rapids Women's Health dba Female Pelvic Medicine and Urogynecology Institute of Michigan
Grand Rapids, Michigan, 49503, United States
HealthCare Midwest
Kalamazoo, Michigan, 49008, United States
Rheumatology PC
Kalamazoo, Michigan, 49009-2175, United States
Beyer Research
Kalamazoo, Michigan, 49009, United States
Beaumont Hospitals - Royal Oak
Royal Oak, Michigan, 48073, United States
Michigan Institute of Urology, P.C.
Troy, Michigan, 48084, United States
CRL Imaging Southdale (x-rays only)
Edina, Minnesota, 55435, United States
Medical Advanced Pain Specialists Applied Research Center Incorporated
Edina, Minnesota, 55435, United States
Southeast Urology Network
Southaven, Mississippi, 38671, United States
Family Health Care Center (X-Ray)
Lincoln, Nebraska, 68506, United States
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, 68510, United States
Capital Region Urological Surgeons
Albany, New York, 12208, United States
Benedictine Hospital
Kingston, New York, 12401, United States
Hudson Valley Urology, PC
Kingston, New York, 12401, United States
University Urology Associates
New York, New York, 10016, United States
DRA Imaging, PC (X-Rays Only)
Poughkeepsie, New York, 12601, United States
Hudson Valley Urology, PC
Poughkeepsie, New York, 12601, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of Rochester, Department of Urology
Rochester, New York, 14642, United States
Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Salisbury Urological Clinic
Salisbury, North Carolina, 28144, United States
Piedmont Medical Research
Winston-Salem, North Carolina, 27103, United States
Tri-State Urologic Services PSC, Inc. dba The Urology Group
Cincinnati, Ohio, 45212, United States
Central Ohio Urology Group
Cofumbus, Ohio, 43221, United States
Columbus Urology Research, LLC
Columbus, Ohio, 43220, United States
Premier Urology
Westerville, Ohio, 43081, United States
Legacy Clinical Research, LLC
Oklahoma City, Oklahoma, 73109, United States
Planned Parenthood of Arkansas and Eastern Oklahoma
Tulsa, Oklahoma, 74105, United States
Oklahoma State University
Tulsa, Oklahoma, 74127, United States
Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103, United States
Urologic Consultants of Southeastern Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004, United States
Jeanes Hospital
Philadelphia, Pennsylvania, 19111, United States
Matrix Research, LLC
Greer, South Carolina, 29650, United States
The Urology Group
Greer, South Carolina, 29650, United States
Bristol Urological Associates, PC
Bristol, Tennessee, 37620, United States
TriCities Medical Research
Bristol, Tennessee, 37620, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920, United States
University Urology
Knoxville, Tennessee, 37920, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
The Neurology Clinic
Memphis, Tennessee, 38018, United States
Southeast Urology Network
Memphis, Tennessee, 38119, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Access Clinical Trials, Inc (ACT)
Nashville, Tennessee, 37203, United States
Center for Urological Treatment
Nashville, Tennessee, 37203, United States
Diagnostic Health
Nashville, Tennessee, 37203, United States
Swan and Brennan, Incorporated
Nashville, Tennessee, 37203, United States
The Center for Reproductive Health
Nashville, Tennessee, 37203, United States
Mobley Research Center
Houston, Texas, 77024, United States
Advances In Health, Inc.
Houston, Texas, 77030, United States
St. Luke's Diagnostic and Treatment Center Kirby Glen
Houston, Texas, 77030, United States
Centex Research, Inc.
Houston, Texas, 77062, United States
Rocky Mountain Neurological Associates
Murray, Utah, 84107, United States
Salt Lake Surgical Center
Murray, Utah, 84107, United States
Salt Lake Regional Medical Center (X-rays only)
Salt Lake City, Utah, 84102, United States
Salt Lake Research, PLLC
Salt Lake City, Utah, 84107, United States
Western Urological Clinic, PC
Salt Lake City, Utah, 84124, United States
Integrity Medical Research, LLC
Mountlake Terrace, Washington, 98043, United States
Urology Northwest
Mountlake Terrace, Washington, 98043, United States
Marc Kirschner, MD
Seattle, Washington, 98133, United States
Universitair Ziekenhuis Brussel
Brussels, B-1090, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, B-2650, Belgium
Universitair Ziekenhuis Gent
Ghent, B-9000, Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, B-3000, Belgium
The Gateway 2
Abbotsford, British Columbia, V2S 3N5, Canada
The Male/Female Health and Research Centre, Royal Court Medical Centre
Barrie, Ontario, L4M 7G1, Canada
Centre for Applied Urological Research
Kingston, Ontario, K7L 3J7, Canada
Kingston General Hospital
Kingston, Ontario, K7N 2V7, Canada
Urology Associates / Urologic Medical Research
Kitchener, Ontario, N2N 2B9, Canada
Anthony Skehan Medicine Professional Corporation
Thunder Bay, Ontario, P7E 6E7, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Kouvolan Laakariasema
Kouvola, 45200, Finland
Department of Obstetrics & Gynaecology, Prince of Wales Hospital The Chinese University of Hong Kong
Shatin, NEW Territories, 0, Hong Kong
Department of Surgery, The Chinese University of Hong Kong
Shatin, Hong Kong
Harasanshin Hospital, Urology
Fukuoka, Fukuoka, 812-0033, Japan
Kyoto City Hospital, Urology
Nakagyo-ku, Kyoto-shi, Kyoto, 604-8845, Japan
Tokyo Women's Medical University Medical Center East
Arakawa-ku, Tokyo, 116-8567, Japan
Tokyo University Hospital
Bunkyo-ku, Tokyo, 113-8655, Japan
SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego, Oddzial Urologii
Bialystok, 15-950, Poland
Conti Medica Sp. z o.o.
Warsaw, 00-846, Poland
Spoldzielnia Pracy Specjalistow Radiologow
Warsaw, 01-194, Poland
NZOZ Centrum Medyczne Wola
Warsaw, 01-432, Poland
Szpital Kliniczny Dzieciatka Jezus, Centrum Leczenia Obrazen
Warsaw, 02-005, Poland
Dinu Uromedica SCM
Bucharest, Sector 4, 041345, Romania
Spitalul Clinic Prof. Dr. Th. Burghele
Bucharest, 050653, Romania
Centrul Medical Sf. Pantelimon
Pantelimon, Romania
Federal State Institution Scientific Research Institute of Urology of Rosmedtechnology
Moscow, 105425, Russia
Urology of Rosmedtechnology
Moscow, 105425, Russia
Saint-Petersburg State Healthcare Institution City Hospital # 15/Department of Urology
Saint Petersburg, 198205, Russia
SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava
Saint Petersburg, filial 1 197022, Russia
SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava/Chair of Urology
Saint Petersburg, filial 1, 197022, Russia
Martinska fakultna nemocnica
Martin, 036 59, Slovakia
Univerzitna nemocnica Martin
Martin, 036 59, Slovakia
MILAB s.r.o.
Prešov, 080 01, Slovakia
Department of Urology, Asan Medical Center, University of Ulsan
Songpa-gu, Seoul, 138-736, South Korea
Department of Urology, Seoul National University Hospital
Seoul, 110-744, South Korea
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710, South Korea
Department of Urology, Korea University Anam Hospital
Seoul, 136-705, South Korea
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Clinica Del Remei - Instituto Medico Tecnologico
Barcelona, 08024, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, 08036, Spain
Kliniska provningsenheten
Gothenburg, 413 45, Sweden
Medicinsk Rontgen (x-ray only)
Malmo, 211 36, Sweden
Center for Lakemedelsprovning Malmo
Malmo, 211 52, Sweden
Chang Gung Medical Foundation - Kaohsiung/Department of Surgery
Koahsiung Hsien, 833, Taiwan
Taichung Hospital, Department of Health, Executive Yuan
Taichung, 403, Taiwan
Taipei Veterans General Hospital (X-Ray Only)
Taipei, 112, Taiwan
Taipei Veterans General Hospital/Department of Surgery
Taipei, 112, Taiwan
Related Publications (1)
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
PMID: 32734597DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated due to lack of efficacy of all doses of tanezumab demonstrated during pre-planned interim analysis.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2009
First Posted
October 21, 2009
Study Start
January 22, 2010
Primary Completion
November 17, 2010
Study Completion
January 21, 2011
Last Updated
August 3, 2021
Results First Posted
August 3, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.