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

March 16, 2011 updated by: Pfizer

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3N1
        • Pfizer Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Pfizer Investigational Site
      • Kingston, Ontario, Canada, K7L 2V7
        • Pfizer Investigational Site
      • Kingston, Ontario, Canada, K7L 3J7
        • Pfizer Investigational Site
      • Kitchener, Ontario, Canada, N2N 2B9
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M6A 3B5
        • Pfizer Investigational Site
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Pfizer Investigational Site
  • Denmark
      • Herlev, Denmark, 2730
        • Pfizer Investigational Site
  • Finland
      • Helsinki, Finland, 00290
        • Pfizer Investigational Site
      • Kouvola, Finland, 45200
        • Pfizer Investigational Site
      • OYS, Finland, 90029
        • Pfizer Investigational Site
      • Seinajoki, Finland, 60220
        • Pfizer Investigational Site
      • Tampere, Finland, 33521
        • Pfizer Investigational Site
  • France
      • Lyon Cedex 03, France, 69437
        • Pfizer Investigational Site
      • Nantes Cedex 1, France, 44093
        • Pfizer Investigational Site
      • Nimes Cedex 9, France, 30029
        • Pfizer Investigational Site
      • Paris, France, 75020
        • Pfizer Investigational Site
      • Rennes Cedex 9, France, 35033
        • Pfizer Investigational Site
      • Strasbourg, France, 67091
        • Pfizer Investigational Site
  • Germany
      • Homburg, Germany, 66424
        • Pfizer Investigational Site
      • Muenchen, Germany, 81679
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • Arizona
      • Goodyear, Arizona, United States, 85395
        • Pfizer Investigational Site
      • Litchfield Park, Arizona, United States, 85340
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85032
        • Pfizer Investigational Site
    • California
      • Glendora, California, United States, 91741
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Pfizer Investigational Site
    • Florida
      • Orlando, Florida, United States, 32804
        • Pfizer Investigational Site
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Pfizer Investigational Site
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Pfizer Investigational Site
      • Watertown, Massachusetts, United States, 02472
        • Pfizer Investigational Site
    • New York
      • Garden City, New York, United States, 11530
        • Pfizer Investigational Site
      • Poughkeepsie, New York, United States, 12601
        • Pfizer Investigational Site
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Pfizer Investigational Site
      • West Chester, Ohio, United States, 45069
        • Pfizer Investigational Site
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Pfizer Investigational Site
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
      • Mt. Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99208
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
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
Experimental: PD 0299685 15mg
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
Experimental: PD 0299685 30mg
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
Time Frame: 12 WEEKS
12 WEEKS
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
Time Frame: 12 WEEKS
12 WEEKS

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.
Time Frame: 12 weeks
12 weeks
ICSI at other time points
Time Frame: 12 weeks
12 weeks
Interstitial Cystitis Problem Index (ICPI)
Time Frame: 12 weeks
12 weeks
Pelvic pain Urgency Frequency score (PUF)
Time Frame: 12 weeks
12 weeks
Epworth Sleepiness Scale (ESS)
Time Frame: 12 Weeks
12 Weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: 15 Weeks
15 Weeks
Adverse events
Time Frame: 15 Weeks
15 Weeks
Physical examination
Time Frame: 14 Weeks
14 Weeks
Vital signs and weight
Time Frame: 15 Weeks
15 Weeks
ECG
Time Frame: 14 Weeks
14 Weeks
Residual urine volume measurement
Time Frame: 14 Weeks
14 Weeks
Global Response assessment (GRA)
Time Frame: 12 Weeks
12 Weeks
Patient Reported Treatment Impact (PRTI)
Time Frame: 12 Weeks
12 Weeks
Treatment failures
Time Frame: 12 Weeks
12 Weeks
Average and worst daily pain score at other time points as measured by an 11-point NRS.
Time Frame: 12 Weeks
12 Weeks
Sleep disturbance and sexual activity pain.
Time Frame: 12 Weeks
12 Weeks
Clinical laboratory tests
Time Frame: 14 Weeks
14 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A4291043

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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