NCT00275379

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
3 countries

16 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

First QC Date

January 9, 2006

Last Update Submit

September 28, 2020

Conditions

Cystitis, Interstitial

Keywords

Cystitis

Outcome Measures

Primary Outcomes (3)

  • 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

  • +2 more secondary outcomes

Interventions

ERB-041DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Glendora, California, 91741, United States

Location

Unknown Facility

Redding, California, 96001, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

Aventura, Florida, 33180, United States

Location

Unknown Facility

Kansas City, Kansas, 66160, United States

Location

Unknown Facility

Jackson, Michigan, 49201, United States

Location

Unknown Facility

Springfield, Oregon, 97477, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19140, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19146, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Temple, Texas, 76508, United States

Location

Unknown Facility

Mountlake Terrace, Washington, 98043, United States

Location

Unknown Facility

Baden, A-2500, Austria

Location

Unknown Facility

Homburg/Saar, 66421, Germany

Location

Unknown Facility

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Cystitis, InterstitialCystitis

Interventions

ERB 041

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Monitor

    For Germany, MedinfoDEU@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Austria, WPVIMED@wyeth.com

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 11, 2006

Study Start

August 1, 2006

Last Updated

October 1, 2020

Record last verified: 2020-09

Locations

US(13)AU(1)DE(2)