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.

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: Completed
• Conditions: Interstitial Cystitis; Painful Bladder Syndrome
• Intervention / Treatment: Drug: PD 0299685 at 15mg BID; Drug: PD 0299685 at 30mg BID; Drug: placebo for PD 0299685

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Columbia-Suicide Severity Rating Scale (C-SSRS)	15 Weeks
Adverse events	15 Weeks
Physical examination	14 Weeks
Vital signs and weight	15 Weeks
ECG	14 Weeks
Residual urine volume measurement	14 Weeks
Global Response assessment (GRA)	12 Weeks
Patient Reported Treatment Impact (PRTI)	12 Weeks
Treatment failures	12 Weeks
Average and worst daily pain score at other time points as measured by an 11-point NRS.	12 Weeks
Sleep disturbance and sexual activity pain.	12 Weeks
Clinical laboratory tests	14 Weeks

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: August 20, 2008
• First Submitted That Met QC Criteria: August 20, 2008
• First Posted (Estimate): August 22, 2008

Study Record Updates

• Last Update Posted (Estimate): March 28, 2011
• Last Update Submitted That Met QC Criteria: March 16, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Disease; Syndrome; Cystitis; Pain; Cystitis, Interstitial
• Other Study ID 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