NCT00245947

Brief Summary

Evaluate the response of inflammatory serum markers to oral ERB-041 in subjects with inflammation associated with active Crohn's disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2004

Status
completed

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

Study Start

First participant enrolled

April 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
Last Updated

September 10, 2009

Status Verified

September 1, 2009

Enrollment Period

1 year

First QC Date

October 26, 2005

Last Update Submit

September 9, 2009

Conditions

Crohn's Disease

Keywords

Crohn's DiseaseInflammation

Outcome Measures

Primary Outcomes (3)

  • Inflammatory serum markers

  • Pharmacogenomics

  • Safety

Secondary Outcomes (3)

  • Crohn's Disease Activity Index (CDAI) scores.

  • Cell surface markers

  • Fecal markers

Interventions

ERB-041DRUG

Eligibility Criteria

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

You may qualify if:

  • Men and women, minimum 18 years of age with a diagnosis of Crohn's disease greater than 3 months,
  • Eligible subjects must have adequate hematologic, renal, and hepatic function.

You may not qualify if:

  • Use of the following medications within the specified time period before randomization is prohibited:
  • Within 48 hours before randomization
  • Nonsteroidal antiinflammatory drugs (NSAIDs) Within 2 weeks before randomization
  • Herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn DiseaseInflammation

Interventions

ERB 041

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 28, 2005

Study Start

April 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

September 10, 2009

Record last verified: 2009-09