MedTrace Logo

High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children

NCT00495521 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-09-21

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

4-Aminosalicylic acid extended release granules

Granules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm

Sponsors & Collaborators

  • Jacobus Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • David P Jacobus, MD · Jacobus Pharmaceutical

  • Kathy L Ales, MD · Jacobus Pharmaceutical

  • George D Ferry, MD · Texas Children's Hospital, Baylor College of Medicine

  • Marla C Dubinsky, MD · Cedars-Sinai Medical Center

  • Joel R Rosh, MD · Atlantic Health System, Morristown General Hospital, Goryeb Children's Hospital

  • Melvin B. Heyman, M.D., M.P.H. · University of California, San Francisco

  • Stanley A. Cohen, M.D. · Children's Center for Digestive Healthcare, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-07-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00495521 on ClinicalTrials.gov