Clinical trial NCT00739739: An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Interstitial Cystitis
Painful Bladder Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
timeFrame: 12 WEEKS
measure: Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
timeFrame: 12 WEEKS
Secondary outcomes:
measure: Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.
timeFrame: 12 weeks
measure: ICSI at other time points
timeFrame: 12 weeks
measure: Interstitial Cystitis Problem Index (ICPI)
timeFrame: 12 weeks
measure: Pelvic pain Urgency Frequency score (PUF)
timeFrame: 12 weeks
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 12 Weeks
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 15 Weeks
measure: Adverse events
timeFrame: 15 Weeks
measure: Physical examination
timeFrame: 14 Weeks
measure: Vital signs and weight
timeFrame: 15 Weeks
measure: ECG
timeFrame: 14 Weeks
measure: Residual urine volume measurement
timeFrame: 14 Weeks
measure: Global Response assessment (GRA)
timeFrame: 12 Weeks
measure: Patient Reported Treatment Impact (PRTI)
timeFrame: 12 Weeks
measure: Treatment failures
timeFrame: 12 Weeks
measure: Average and worst daily pain score at other time points as measured by an 11-point NRS.
timeFrame: 12 Weeks
measure: Sleep disturbance and sexual activity pain.
timeFrame: 12 Weeks
measure: Clinical laboratory tests
timeFrame: 14 Weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Goodyear
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Litchfield Park
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Glendora
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jeffersonville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Brighton
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Garden City
country: United States
facility: Pfizer Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Pfizer Investigational Site
state: New York
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: West Chester
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bethany
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: State College
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Barrie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Herlev
country: Denmark
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Kouvola
country: Finland
facility: Pfizer Investigational Site
city: OYS
country: Finland
facility: Pfizer Investigational Site
city: Seinajoki
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Lyon Cedex 03
country: France
facility: Pfizer Investigational Site
city: Nantes Cedex 1
country: France
facility: Pfizer Investigational Site
city: Nimes Cedex 9
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Rennes Cedex 9
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Homburg
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Nickel JC, Crossland A, Davis E, Haab F, Mills IW, Rovner E, Scholfield D, Crook T. Investigation of a Ca2+ channel alpha2delta 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.