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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00275379

Enrollment

Registered

2006-01-11

Start date

2006-08-31

Completion date

Unknown

Last updated

2020-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystitis, Interstitial

Keywords

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.

Interventions

DRUGERB-041

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety	—
Levels of urinary antiproliferative factor (APF)	—
Peripheral blood mononuclear cell (PBMC) gene expression profiles	—

Secondary

Measure	Time frame
Voiding Diary	—
Serum and urinary biomarkers of IC	—
Clinical Activity:	—
O'Leary-Sant IC Symptom (ICSI) and Problem (ICPI) Index	—
Global Response Assessment (GRA)	—
Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale	—
Female Sexual Function Index (FSFI)	—

Countries

Austria, Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026