Study Evaluating ERB-041 in Active Crohn's Disease

Wyeth

Status and phase: Completed; Phase 1

Conditions: Crohn's Disease

Treatments: Drug: ERB-041

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245947

3142A3-102

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind