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

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00275379
First received: January 9, 2006
Last updated: March 14, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention
Cystitis, Interstitial
Drug: ERB-041

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Safety
  • Levels of urinary antiproliferative factor (APF)
  • Peripheral blood mononuclear cell (PBMC) gene expression profiles

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

Estimated Enrollment: 60
Study Start Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275379

Locations
United States, California
Glendora, California, United States, 91741
Redding, California, United States, 96001
San Diego, California, United States, 92103
United States, Florida
Aventura, Florida, United States, 33180
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Michigan
Jackson, Michigan, United States, 49201
United States, Oregon
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19140
Philadelphia, Pennsylvania, United States, 19146
United States, Texas
Houston, Texas, United States, 77030
Temple, Texas, United States, 76508
United States, Washington
Mountlake Terrace, Washington, United States, 98043
Austria
Baden, Austria, A-2500
Germany
Homburg/Saar, Germany, 66421
Munster, Germany, 48149
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Monitor For Germany, MedinfoDEU@wyeth.com
Principal Investigator: Trial Manager For Austria, WPVIMED@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00275379     History of Changes
Other Study ID Numbers: 3142A4-109
Study First Received: January 9, 2006
Last Updated: March 14, 2007
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Ministry for Health and Women

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Cystitis

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 19, 2014