Status:
WITHDRAWN
Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Cystitis, Interstitial
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00275379
Start Date
August 1 2006
Last Update
October 1 2020
Active Locations (16)
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1
Glendora, California, United States, 91741
2
Redding, California, United States, 96001
3
San Diego, California, United States, 92103
4
Aventura, Florida, United States, 33180