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

Withdrawn before enrolling · Not applicable

Conditions studied: Cystitis, Interstitial

In brief

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.

Key facts

Study ID

NCT00275379

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

0

Starts

2006-08-01

Last updated by the study team

2020-10-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Glendora, California, United States
• Study site — Redding, California, United States
• Study site — San Diego, California, United States
• Study site — Aventura, Florida, United States
• Study site — Kansas City, Kansas, United States
• Study site — Jackson, Michigan, United States
• Study site — Springfield, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — Temple, Texas, United States
• Study site — Mountlake Terrace, Washington, United States
• Study site — Baden, Austria
• Study site — Homburg/Saar, Germany
• Study site — Münster, Germany

Full record on ClinicalTrials.gov

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