Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
This study has been terminated.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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
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 May 23, 2013