Study Evaluating ERB-041 in Active Crohn's Disease

Wyeth is now a wholly owned subsidiary of Pfizer22 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Crohn's Disease

Interventions

ERB-041DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Inflammatory serum markers

Pharmacogenomics

Safety

Secondary Outcomes

Crohn's Disease Activity Index (CDAI) scores.

Cell surface markers

Fecal markers

Data from ClinicalTrials.gov

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