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

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NCT00999518

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Study Location
Alabama Orthopaedic Clinic
Mobile, Alabama, 36608, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Interstitial Cystitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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%.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
Official Title  ICMJE 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cystitis, Interstitial
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Group 1
    Intervention: Biological: Tanezumab
  • Experimental: Group 2
    Intervention: Biological: Tanezumab
  • Experimental: Group 3
    Intervention: Biological: Tanezumab
  • Experimental: Group 4
    Intervention: Biological: Tanezumab
  • Placebo Comparator: Group 5
    Intervention: Other: Placebo
Publications * 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:CD013325. doi: 10.1002/14651858.CD013325.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 23, 2019)		205
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2009)		360
Actual Study Completion Date  ICMJE January 21, 2011
Actual Primary Completion Date November 17, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Finland,   Hong Kong,   Japan,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Taiwan,   United States
Removed Location Countries Germany,   India,   South Africa
 
Administrative Information
NCT Number  ICMJE NCT00999518
Other Study ID Numbers  ICMJE A4091035
2009-014597-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description: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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP