Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Terminated Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00495521

Public ClinicalTrials.gov record NCT00495521. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 4:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00495521
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Jacobus Pharmaceutical
Industry
Enrollment
2 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2007 (Type not available)
Primary completion
Jul 2008 (Actual)
Completion
Oct 2008 (Actual)
Last update posted
Sep 21, 2017

2007 – 2008

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
Cedars-Sinai Medical Center Los Angeles California 90048 —
University of California, San Francisco San Francisco California 94143-0316 —
Children's Center for Digestive HealthCare, LLC Atlanta Georgia 30342 —
Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital Morristown New Jersey 07962 —
Texas Children's Hospital, Baylor College of Medicine Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00495521, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 21, 2017 · Synced Oct 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00495521 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →