drugset / Trial / NCT00495521
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.
Timeline
- Start
- 2007-06
- Primary completion
- 2008-07
- Completion
- 2008-10
Outcome
Outcome not reported
Stopped (Enrollment): “Efforts at recruitment have halted as recruitment was poor”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 4-Aminosalicylic acid | Unknown | 50 mg/kg | Oral |