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An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Interstitial Cystitis, Painful Bladder Syndrome
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

- Men and women over 18 years of age with moderate to severe interstitial cystitis
defined by pain score.

- Women must not be pregnant or lactating, They may be post-menopausal, surgically
sterilized or using an appropriate method of contraception.

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

- History of interstitial cystitis less than 6 months

- History of current or recurrent urinary tract infections, or genitourinary cancer

- Any previous urinary diversion procedure with or without bladder removal, bladder
augmentation

- Use of certain drugs given into the bladder up to 1 month prior to study entry

NCT00739739
Pfizer
Completed
An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis

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An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis
A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.
The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Interstitial Cystitis
  • Painful Bladder Syndrome
  • Drug: PD 0299685 at 15mg BID
    5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
  • Drug: PD 0299685 at 30mg BID
    10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID.
  • Drug: placebo for PD 0299685
    Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study
  • Experimental: PD 0299685 15mg
    Intervention: Drug: PD 0299685 at 15mg BID
  • Experimental: PD 0299685 30mg
    Intervention: Drug: PD 0299685 at 30mg BID
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo for PD 0299685
Nickel JC, Crossland A, Davis E, Haab F, Mills IW, Rovner E, Scholfield D, Crook T. Investigation of a Ca2+ channel ?2? ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial. J Urol. 2012 Sep;188(3):817-23. doi: 10.1016/j.juro.2012.05.010. Epub 2012 Jul 19.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
161
January 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women over 18 years of age with moderate to severe interstitial cystitis defined by pain score.
  • Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception.

Exclusion Criteria:

  • History of interstitial cystitis less than 6 months
  • History of current or recurrent urinary tract infections, or genitourinary cancer
  • Any previous urinary diversion procedure with or without bladder removal, bladder augmentation
  • Use of certain drugs given into the bladder up to 1 month prior to study entry
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Denmark,   Finland,   France,   Germany,   United States
 
 
NCT00739739
A4291043
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2011

ICMJE     Data element required by the

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

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