Cystitis, InterstitialNCT00275379
Study Evaluating Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
A study testing ERB-041 in people with Cystitis, Interstitial, run by Wyeth is now a wholly owned subsidiary of Pfizer at 16 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystitis, Interstitial
- What is being tested?
- ERB-041
- How many people
- 0 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Aug 2006to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States13 sites
Study site
Aventura, Florida, 33180
Study site
Glendora, California, 91741
Study site
Houston, Texas, 77030
Study site
Jackson, Michigan, 49201
Study site
Kansas City, Kansas, 66160
Study site
Mountlake Terrace, Washington, 98043
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19140
Study site
Philadelphia, Pennsylvania, 19146
Study site
Redding, California, 96001
Study site
San Diego, California, 92103
Study site
Springfield, Oregon, 97477
Study site
Temple, Texas, 76508
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
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.
- Conditions
- Cystitis, Interstitial
- Being tested
- ERB-041
- Keywords
- Cystitis
- Medical subject headings
- Cystitis, Interstitial, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERB-041Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Levels of urinary antiproliferative factor (APF)
Peripheral blood mononuclear cell (PBMC) gene expression profiles
Secondary outcomes (7)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystitis, InterstitialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Monitor, Principal investigator, For Germany, MedinfoDEU@wyeth.comTrial Manager, Principal investigator, For Austria, WPVIMED@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275379
- Sponsor's protocol ID
- 3142A4-109
- Other IDs
- B2381036
- Status last verified
- Sep 2020
- First submitted
- 9 Jan 2006
- Last updated
- 1 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Exploratory Study of Orally Administered ERB-041 in Subjects With Active Interstitial Cystitis
- ClinicalTrials.gov ID
- NCT00275379
- Acronym / sponsor ID
- 3142A4-109
- Conditions
- Cystitis, Interstitial
- Keywords
- Cystitis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- First posted
- 11 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERB-041 | Drug | – |
Primary outcome
Safety
Levels of urinary antiproliferative factor (APF)
Peripheral blood mononuclear cell (PBMC) gene expression profiles
7 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Monitor principal investigator
For Germany, MedinfoDEU@wyeth.com
Trial Manager principal investigator
For Austria, WPVIMED@wyeth.com
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERB-041 in people with Cystitis, Interstitial, run by Wyeth is now a wholly owned subsidiary of Pfizer at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020; AzTrials last refreshed its copy on 3 Nov 2026.