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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00275379 |
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Date of registration:
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09/01/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
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Scientific title:
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT00275379 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
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Phase:
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N/A
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Countries of recruitment
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Austria
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Germany
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United States
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Austria, WPVIMED@wyeth.com |
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Name:
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Trial Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Germany, MedinfoDEU@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cystitis, Interstitial
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Intervention(s)
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Drug: ERB-041
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Primary Outcome(s)
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Peripheral blood mononuclear cell (PBMC) gene expression profiles
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Safety
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Levels of urinary antiproliferative factor (APF)
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Secondary Outcome(s)
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O'Leary-Sant IC Symptom (ICSI) and Problem (ICPI) Index
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Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale
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Voiding Diary
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Global Response Assessment (GRA)
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Serum and urinary biomarkers of IC
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Clinical Activity:
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Female Sexual Function Index (FSFI)
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Secondary ID(s)
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B2381036
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3142A4-109
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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