An Effectiveness and Safety Study of PD 0299685 for the Treatment of Symptoms Associated With Interstitial Cystitis - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00739739

Purpose

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.

Condition	Intervention	Phase
Interstitial Cystitis Painful Bladder Syndrome	Drug: PD 0299685 at 15mg BID Drug: PD 0299685 at 30mg BID Drug: placebo for PD 0299685	Phase II

MedlinePlus related topics: Interstitial Cystitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score. [ Time Frame: 12 WEEKS ] [ Designated as safety issue: No ]
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS). [ Time Frame: 12 WEEKS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
ICSI at other time points [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Interstitial Cystitis Problem Index (ICPI) [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
Pelvic pain Urgency Frequency score (PUF) [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
Epworth Sleepiness Scale (ESS) [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 13 Weeks ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
Physical examination [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
Vital signs and weight [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
ECG [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
Residual urine volume measurement [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]
Global Response assessment (GRA) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Patient Reported Treatment Impact (PRTI) [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
Treatment failures [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Average and worst daily pain score at other time points as measured by an 11-point NRS. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Sleep disturbance and sexual activity pain. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Clinical laboratory tests [ Time Frame: 13 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	129
Study Start Date:	August 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PD 0299685 15mg: Experimental	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 30mg: Experimental	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.
Placebo: Placebo Comparator	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women over 18 years of age with moderate to severe interstitial cystitis
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739739

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 26 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4291043
Study First Received:	August 20, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00739739
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cystitis, Interstitial
Cystocele
Urologic Diseases

Urinary Bladder Diseases
Cystitis
Pain

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009