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

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NCT00999518

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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%.

NCT00999518
Pfizer
Terminated
A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome

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[email protected]

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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)
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
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Cystitis, Interstitial
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
222
November 2010
November 2010   (Final data collection date for primary outcome measure)

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%.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Finland,   Hong Kong,   Japan,   Korea, Republic of,   Poland,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Taiwan,   United States
Germany,   India,   South Africa
 
NCT00999518
A4091035
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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