Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis

Not Applicable

Withdrawn

• Conditions: Cystitis, Interstitial

• Registration Number: NCT00275379
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-09
• Study First Submitted QC: 2006-01-09
• Study First Posted: 2006-01-11
• Study Start: 2006-08
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety
Peripheral blood mononuclear cell (PBMC) gene expression profiles
Levels of urinary antiproliferative factor (APF)

Secondary Outcome Measures

Name	Time	Method
Clinical Activity:
Serum and urinary biomarkers of IC
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