Clinical Trial: Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
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 Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Current Primary Outcome:
- Safety
- Levels of urinary antiproliferative factor (APF)
- Peripheral blood mononuclear cell (PBMC) gene expression profiles
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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
Original Secondary Outcome: Same as current
Information By: Wyeth is now a wholly owned subsidiary of Pfizer
Dates:
Date Received: January 9, 2006
Date Started: August 2006
Date Completion:
Last Updated: March 14, 2007
Last Verified: March 2007