search
Back to results

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

Primary Purpose

Interstitial Cystitis, Painful Bladder Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PD 0299685 at 15mg BID
PD 0299685 at 30mg BID
placebo for PD 0299685
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

PD 0299685 15mg

PD 0299685 30mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).

Secondary Outcome Measures

Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.
ICSI at other time points
Interstitial Cystitis Problem Index (ICPI)
Pelvic pain Urgency Frequency score (PUF)
Epworth Sleepiness Scale (ESS)
Columbia-Suicide Severity Rating Scale (C-SSRS)
Adverse events
Physical examination
Vital signs and weight
ECG
Residual urine volume measurement
Global Response assessment (GRA)
Patient Reported Treatment Impact (PRTI)
Treatment failures
Average and worst daily pain score at other time points as measured by an 11-point NRS.
Sleep disturbance and sexual activity pain.
Clinical laboratory tests

Full Information

First Posted
August 20, 2008
Last Updated
March 16, 2011
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00739739
Brief Title
An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Painful Bladder Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD 0299685 15mg
Arm Type
Experimental
Arm Title
PD 0299685 30mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PD 0299685 at 15mg BID
Intervention Description
5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
Intervention Type
Drug
Intervention Name(s)
PD 0299685 at 30mg BID
Intervention Description
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
Intervention Name(s)
placebo for PD 0299685
Intervention Description
Capsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study
Primary Outcome Measure Information:
Title
Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
Time Frame
12 WEEKS
Title
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
Time Frame
12 WEEKS
Secondary Outcome Measure Information:
Title
Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.
Time Frame
12 weeks
Title
ICSI at other time points
Time Frame
12 weeks
Title
Interstitial Cystitis Problem Index (ICPI)
Time Frame
12 weeks
Title
Pelvic pain Urgency Frequency score (PUF)
Time Frame
12 weeks
Title
Epworth Sleepiness Scale (ESS)
Time Frame
12 Weeks
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
15 Weeks
Title
Adverse events
Time Frame
15 Weeks
Title
Physical examination
Time Frame
14 Weeks
Title
Vital signs and weight
Time Frame
15 Weeks
Title
ECG
Time Frame
14 Weeks
Title
Residual urine volume measurement
Time Frame
14 Weeks
Title
Global Response assessment (GRA)
Time Frame
12 Weeks
Title
Patient Reported Treatment Impact (PRTI)
Time Frame
12 Weeks
Title
Treatment failures
Time Frame
12 Weeks
Title
Average and worst daily pain score at other time points as measured by an 11-point NRS.
Time Frame
12 Weeks
Title
Sleep disturbance and sexual activity pain.
Time Frame
12 Weeks
Title
Clinical laboratory tests
Time Frame
14 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Pfizer Investigational Site
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85395
Country
United States
Facility Name
Pfizer Investigational Site
City
Litchfield Park
State/Province
Arizona
ZIP/Postal Code
85340
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Pfizer Investigational Site
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pfizer Investigational Site
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Pfizer Investigational Site
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Pfizer Investigational Site
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Pfizer Investigational Site
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Pfizer Investigational Site
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Pfizer Investigational Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Pfizer Investigational Site
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Pfizer Investigational Site
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Pfizer Investigational Site
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
Facility Name
Pfizer Investigational Site
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Pfizer Investigational Site
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Pfizer Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Pfizer Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3N1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Pfizer Investigational Site
City
Kouvola
ZIP/Postal Code
45200
Country
Finland
Facility Name
Pfizer Investigational Site
City
OYS
ZIP/Postal Code
90029
Country
Finland
Facility Name
Pfizer Investigational Site
City
Seinajoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Pfizer Investigational Site
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Pfizer Investigational Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Pfizer Investigational Site
City
Nimes Cedex 9
ZIP/Postal Code
30029
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Pfizer Investigational Site
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Pfizer Investigational Site
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Pfizer Investigational Site
City
Homburg
ZIP/Postal Code
66424
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81679
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32734597
Citation
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.
Results Reference
derived
PubMed Identifier
22818144
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4291043&StudyName=An%20Effectiveness%20And%20Safety%20Study%20Of%20PD%200299685%20For%20The%20Treatment%20Of%20Symptoms%20Associated%20With%20Interstitial%20Cystitis
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs