Study Evaluating ERB-041 in Active Crohn's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00245947 |
Recruitment Status :
Completed
First Posted : October 28, 2005
Last Update Posted : September 10, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: ERB-041 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Exploratory Pharmacogenomic, Safety and Activity Study of Orally Administered ERB-041 in Subjects With Inflammation Associated With Active Crohn's Disease |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | April 2005 |
Actual Study Completion Date : | April 2005 |

- Inflammatory serum markers
- Pharmacogenomics
- Safety
- Crohn's Disease Activity Index (CDAI) scores.
- Cell surface markers
- Fecal markers

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Other inclusions apply
Exclusion Criteria:
- 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).
Other exclusions applies

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245947
Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT00245947 |
Other Study ID Numbers: |
3142A3-102 |
First Posted: | October 28, 2005 Key Record Dates |
Last Update Posted: | September 10, 2009 |
Last Verified: | September 2009 |
Crohn's Disease Inflammation |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |