- Documented, signed and dated informed consent to participate in this trial prior to
any study related procedures being performed.
- Men and women age 16 years and over.
- Diagnosis of Crohn's disease for at least 6 months that has been appropriately
documented and confirmed by radiological studies, endoscopy (with histological
examination preferred), or surgical pathology (Patients with a diagnosis of Crohn's
disease for less than 6 months may be included if the diagnosis is confirmed by a
biopsy characteristic of Crohn's disease)
Use of the following medications within the specified time period prior to randomization:
- Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 [COX-2]
inhibitors and >500 mg/day acetylsalicylic acid)
- Codeine-containing compounds
- Corticosteroid enemas