Back to resultsStudy Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
Primary Purpose
Cystitis, Interstitial
Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ERB-041
Sponsored by
About this trial
This is an interventional treatment trial for Cystitis, Interstitial focused on measuring Cystitis
Eligibility Criteria
Inclusion Criteria: Subjects seeking medical treatment for symptoms consistent with IC that have been ongoing for > 9 months or seeking medical treatment for a previous documented diagnosis of IC Subjects who are not surgically sterile or postmenopausal (amenorrheic > 12 months) must agree and commit to the use of a medically acceptable, highly-effective (i.e. double-barrier or IUD), non-hormonal form of birth control during the study and for 30 days after the last dose of test Exclusion Criteria: Use of herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components) History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) with less than 5 years documentation of a disease-free state Vaginitis or vaginal infection within 1 month before randomization
Sites / Locations
Outcomes
Primary Outcome Measures
Safety
Levels of urinary antiproliferative factor (APF)
Peripheral blood mononuclear cell (PBMC) gene expression profiles
Secondary Outcome Measures
Serum and urinary biomarkers of IC
Clinical Activity:
Global Response Assessment (GRA)
O'Leary-Sant IC Symptom (ICSI) and Problem (ICPI) Index
Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale
Female Sexual Function Index (FSFI)
Voiding Diary
Full Information
NCT ID
NCT00275379
First Posted
January 9, 2006
Last Updated
September 28, 2020
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00275379
Brief Title
Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-design, exploratory study of orally administered ERB-041 in subjects with active IC. The primary objectives of this study will be to investigate ERB-041's activity on levels of urinary APF, explore the gene expression response in peripheral blood mononuclear cells (PBMC), and to evaluate the safety of ERB-041 in women with active IC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Interstitial
Keywords
Cystitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ERB-041
Primary Outcome Measure Information:
Title
Safety
Title
Levels of urinary antiproliferative factor (APF)
Title
Peripheral blood mononuclear cell (PBMC) gene expression profiles
Secondary Outcome Measure Information:
Title
Serum and urinary biomarkers of IC
Title
Clinical Activity:
Title
Global Response Assessment (GRA)
Title
O'Leary-Sant IC Symptom (ICSI) and Problem (ICPI) Index
Title
Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale
Title
Female Sexual Function Index (FSFI)
Title
Voiding Diary
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects seeking medical treatment for symptoms consistent with IC that have been ongoing for > 9 months or seeking medical treatment for a previous documented diagnosis of IC
Subjects who are not surgically sterile or postmenopausal (amenorrheic > 12 months) must agree and commit to the use of a medically acceptable, highly-effective (i.e. double-barrier or IUD), non-hormonal form of birth control during the study and for 30 days after the last dose of test
Exclusion Criteria:
Use of herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components)
History of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) with less than 5 years documentation of a disease-free state
Vaginitis or vaginal infection within 1 month before randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Monitor
Organizational Affiliation
For Germany, MedinfoDEU@wyeth.com
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Austria, WPVIMED@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Glendora
State/Province
California
ZIP/Postal Code
91741
Country
United States
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
City
Baden
ZIP/Postal Code
A-2500
Country
Austria
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
City
Munster
ZIP/Postal Code
48149
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
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