Clinical trialNCT00495521TerminatedPhase 2Interventional

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

SponsorJacobus PharmaceuticalEnrollment2Crohn's Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

David P Jacobus, MD
Jacobus Pharmaceutical
Study Chair
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George D Ferry, MD
Texas Children's Hospital, Baylor College of Medicine
Principal Investigator
clinicaltrials.gov ↗
Joel R Rosh, MD
Atlantic Health System, Morristown General Hospital, Goryeb Children's Hospital
Principal Investigator
clinicaltrials.gov ↗
Kathy L Ales, MD
Jacobus Pharmaceutical
Study Director
clinicaltrials.gov ↗
Marla C Dubinsky, MD
Cedars-Sinai Medical Center
Principal Investigator
clinicaltrials.gov ↗
Melvin B. Heyman, M.D., M.P.H.
University of California, San Francisco
Principal Investigator
clinicaltrials.gov ↗
Stanley A. Cohen, M.D.
Children's Center for Digestive Healthcare, LLC
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Children'S Center for Digestive Healthcare, Llc
Atlanta, Georgia, United States
Atlantic Health System / Morristown Memorial Hospital / Goryeb Children'S Hospital
Morristown, New Jersey, United States
Texas Children'S Hospital, Baylor College of Medicine
Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

4-Aminosalicylic acid extended release granules

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2007
Primary completion: 31 Jul 2008
Completion: 31 Oct 2008
Last update posted: 21 Sept 2017
Registered enrollment: 2
Registry id: NCT00495521

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.