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

Interstitial Cystitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739739
• Other study ID #: A4291043
• Status: Completed
• Phase: Phase 2
• First received: August 20, 2008
• Last updated: March 16, 2011
• Start date: August 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Painful Bladder Syndrome

Intervention

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
• 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.
• 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

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Barrie	Ontario
Canada	Pfizer Investigational Site	Kingston	Ontario
Canada	Pfizer Investigational Site	Kingston	Ontario
Canada	Pfizer Investigational Site	Kitchener	Ontario
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Victoria	British Columbia
Denmark	Pfizer Investigational Site	Herlev
Finland	Pfizer Investigational Site	Helsinki
Finland	Pfizer Investigational Site	Kouvola
Finland	Pfizer Investigational Site	OYS
Finland	Pfizer Investigational Site	Seinajoki
Finland	Pfizer Investigational Site	Tampere
France	Pfizer Investigational Site	Lyon Cedex 03
France	Pfizer Investigational Site	Nantes Cedex 1
France	Pfizer Investigational Site	Nimes Cedex 9
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Rennes Cedex 9
France	Pfizer Investigational Site	Strasbourg
Germany	Pfizer Investigational Site	Homburg
Germany	Pfizer Investigational Site	Muenchen
United States	Pfizer Investigational Site	Bethany	Oklahoma
United States	Pfizer Investigational Site	Brighton	Massachusetts
United States	Pfizer Investigational Site	Burlington	North Carolina
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Farmington	Connecticut
United States	Pfizer Investigational Site	Garden City	New York
United States	Pfizer Investigational Site	Glendora	California
United States	Pfizer Investigational Site	Goodyear	Arizona
United States	Pfizer Investigational Site	Jeffersonville	Indiana
United States	Pfizer Investigational Site	Litchfield Park	Arizona
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Mt. Pleasant	South Carolina
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Poughkeepsie	New York
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	State College	Pennsylvania
United States	Pfizer Investigational Site	Watertown	Massachusetts
United States	Pfizer Investigational Site	West Chester	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Finland,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.		12 WEEKS	No
Primary	Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).		12 WEEKS	No
Secondary	Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.		12 weeks	No
Secondary	ICSI at other time points		12 weeks	No
Secondary	Interstitial Cystitis Problem Index (ICPI)		12 weeks	No
Secondary	Pelvic pain Urgency Frequency score (PUF)		12 weeks	No
Secondary	Epworth Sleepiness Scale (ESS)		12 Weeks	Yes
Secondary	Columbia-Suicide Severity Rating Scale (C-SSRS)		15 Weeks	Yes
Secondary	Adverse events		15 Weeks	Yes
Secondary	Physical examination		14 Weeks	Yes
Secondary	Vital signs and weight		15 Weeks	Yes
Secondary	ECG		14 Weeks	Yes
Secondary	Residual urine volume measurement		14 Weeks	Yes
Secondary	Global Response assessment (GRA)		12 Weeks	No
Secondary	Patient Reported Treatment Impact (PRTI)		12 Weeks	No
Secondary	Treatment failures		12 Weeks	No
Secondary	Average and worst daily pain score at other time points as measured by an 11-point NRS.		12 Weeks	No
Secondary	Sleep disturbance and sexual activity pain.		12 Weeks	No
Secondary	Clinical laboratory tests		14 Weeks	Yes

External Links

•   To obtain contact information for a study center near you, click here.