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