Clinical trial NCT00275379: Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cystitis, Interstitial
Keywords: Cystitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety
measure: Levels of urinary antiproliferative factor (APF)
measure: Peripheral blood mononuclear cell (PBMC) gene expression profiles
Secondary outcomes:
measure: Serum and urinary biomarkers of IC
measure: Clinical Activity:
measure: Global Response Assessment (GRA)
measure: O'Leary-Sant IC Symptom (ICSI) and Problem (ICPI) Index
measure: Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale
measure: Female Sexual Function Index (FSFI)
measure: Voiding Diary
Other outcomes:
Locations:
city: Glendora
country: United States
state: California
city: Redding
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aventura
country: United States
state: Florida
city: Kansas City
country: United States
state: Kansas
city: Jackson
country: United States
state: Michigan
city: Springfield
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Mountlake Terrace
country: United States
state: Washington
city: Baden
country: Austria
city: Homburg/Saar
country: Germany
city: Munster
country: Germany
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, MedinfoDEU@wyeth.com
name: Trial Monitor
role: PRINCIPAL_INVESTIGATOR
affiliation: For Austria, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: