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.
1 other identifier
interventional
161
6 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2008
Shorter than P25 for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 20, 2008
CompletedFirst Posted
Study publicly available on registry
August 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedMarch 28, 2011
March 1, 2011
1.4 years
August 20, 2008
March 16, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
12 WEEKS
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
12 WEEKS
Secondary Outcomes (17)
Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.
12 weeks
ICSI at other time points
12 weeks
Interstitial Cystitis Problem Index (ICPI)
12 weeks
Pelvic pain Urgency Frequency score (PUF)
12 weeks
Epworth Sleepiness Scale (ESS)
12 Weeks
- +12 more secondary outcomes
Study Arms (3)
PD 0299685 15mg
EXPERIMENTALPD 0299685 30mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
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.
Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (44)
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Pfizer Investigational Site
Goodyear, Arizona, 85395, United States
Pfizer Investigational Site
Litchfield Park, Arizona, 85340, United States
Pfizer Investigational Site
Phoenix, Arizona, 85032, United States
Pfizer Investigational Site
Glendora, California, 91741, United States
Pfizer Investigational Site
San Diego, California, 92103, United States
Pfizer Investigational Site
Farmington, Connecticut, 06032, United States
Pfizer Investigational Site
Orlando, Florida, 32804, United States
Pfizer Investigational Site
Jeffersonville, Indiana, 47130, United States
Pfizer Investigational Site
Shreveport, Louisiana, 71106, United States
Pfizer Investigational Site
Brighton, Massachusetts, 02135, United States
Pfizer Investigational Site
Watertown, Massachusetts, 02472, United States
Pfizer Investigational Site
Garden City, New York, 11530, United States
Pfizer Investigational Site
Poughkeepsie, New York, 12601, United States
Pfizer Investigational Site
Burlington, North Carolina, 27215, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45212, United States
Pfizer Investigational Site
West Chester, Ohio, 45069, United States
Pfizer Investigational Site
Bethany, Oklahoma, 73008, United States
Pfizer Investigational Site
State College, Pennsylvania, 16801, United States
Pfizer Investigational Site
Charleston, South Carolina, 29425, United States
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
Pfizer Investigational Site
Nashville, Tennessee, 37232, United States
Pfizer Investigational Site
Spokane, Washington, 99208, United States
Pfizer Investigational Site
Victoria, British Columbia, V8V 3N1, Canada
Pfizer Investigational Site
Barrie, Ontario, L4M 7G1, Canada
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7, Canada
Pfizer Investigational Site
Kingston, Ontario, K7L 3J7, Canada
Pfizer Investigational Site
Kitchener, Ontario, N2N 2B9, Canada
Pfizer Investigational Site
Toronto, Ontario, M6A 3B5, Canada
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 5N4, Canada
Pfizer Investigational Site
Herlev, 2730, Denmark
Pfizer Investigational Site
Helsinki, 00290, Finland
Pfizer Investigational Site
Kouvola, 45200, Finland
Pfizer Investigational Site
OYS, 90029, Finland
Pfizer Investigational Site
Seinäjoki, 60220, Finland
Pfizer Investigational Site
Tampere, 33521, Finland
Pfizer Investigational Site
Lyon, 69437, France
Pfizer Investigational Site
Nantes, 44093, France
Pfizer Investigational Site
Nîmes, 30029, France
Pfizer Investigational Site
Paris, 75020, France
Pfizer Investigational Site
Rennes, 35033, France
Pfizer Investigational Site
Strasbourg, 67091, France
Pfizer Investigational Site
Homburg, 66424, Germany
Pfizer Investigational Site
München, 81679, Germany
Related Publications (2)
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.
PMID: 32734597DERIVEDNickel 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.
PMID: 22818144DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 20, 2008
First Posted
August 22, 2008
Study Start
August 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
March 28, 2011
Record last verified: 2011-03