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

NCT ID: NCT00739739

Last Updated: 2011-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Interstitial Cystitis Painful Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PD 0299685 15mg

Group Type EXPERIMENTAL

PD 0299685 at 15mg BID

Intervention Type DRUG

5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study

PD 0299685 30mg

Group Type EXPERIMENTAL

PD 0299685 at 30mg BID

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

placebo for PD 0299685

Intervention Type DRUG

Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study

Interventions

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PD 0299685 at 15mg BID

5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study

Intervention Type 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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Mobile, Alabama, United States

Site Status

Pfizer Investigational Site

Goodyear, Arizona, United States

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Litchfield Park, Arizona, United States

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Phoenix, Arizona, United States

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Glendora, California, United States

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San Diego, California, United States

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Farmington, Connecticut, United States

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Orlando, Florida, United States

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Jeffersonville, Indiana, United States

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Shreveport, Louisiana, United States

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Brighton, Massachusetts, United States

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Watertown, Massachusetts, United States

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Garden City, New York, United States

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Poughkeepsie, New York, United States

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Burlington, North Carolina, United States

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Cincinnati, Ohio, United States

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West Chester, Ohio, United States

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Bethany, Oklahoma, United States

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State College, Pennsylvania, United States

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Charleston, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Nashville, Tennessee, United States

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Spokane, Washington, United States

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Victoria, British Columbia, Canada

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Barrie, Ontario, Canada

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Kingston, Ontario, Canada

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Kingston, Ontario, Canada

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Kitchener, Ontario, Canada

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Toronto, Ontario, Canada

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Sherbrooke, Quebec, Canada

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Herlev, , Denmark

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Helsinki, , Finland

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Kouvola, , Finland

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OYS, , Finland

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Seinäjoki, , Finland

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Tampere, , Finland

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Lyon, , France

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Nantes, , France

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Nîmes, , France

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Paris, , France

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Rennes, , France

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Strasbourg, , France

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Homburg, , Germany

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München, , Germany

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Countries

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United States Canada Denmark Finland France Germany

References

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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.

Reference Type DERIVED
PMID: 32734597 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22818144 (View on PubMed)

Other Identifiers

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A4291043

Identifier Type: -

Identifier Source: org_study_id

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