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

Cystitis, Interstitial Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00275379
• Other study ID #: 3142A4-109
• Secondary ID: B2381036
• Status: Withdrawn
• Phase: N/A
• Start date: August 2006

Study information

• Verified date: September 2020
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial

Intervention

Drug:
• ERB-041

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Levels of urinary antiproliferative factor (APF)
Primary	Peripheral blood mononuclear cell (PBMC) gene expression profiles
Secondary	Serum and urinary biomarkers of IC
Secondary	Clinical Activity:
Secondary	Global Response Assessment (GRA)
Secondary	O'Leary-Sant IC Symptom (ICSI) and Problem (ICPI) Index
Secondary	Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale
Secondary	Female Sexual Function Index (FSFI)
Secondary	Voiding Diary