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

Information source: Jacobus Pharmaceutical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: PASER or placebo granules (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Jacobus Pharmaceutical

Official(s) and/or principal investigator(s):
David P Jacobus, MD, Study Chair, Affiliation: Jacobus Pharmaceutical
Kathy L Ales, MD, Study Director, Affiliation: Jacobus Pharmaceutical
George D Ferry, MD, Principal Investigator, Affiliation: Texas Children's Hospital, Baylor College of Medicine
Marla C Dubinsky, MD, Principal Investigator, Affiliation: Cedars-Sinai Medical Center
Joel R Rosh, MD, Principal Investigator, Affiliation: Atlantic Health System, Morristown General Hospital, Goryeb Children's Hospital
Melvin B. Heyman, M.D., M.P.H., Principal Investigator, Affiliation: University of California, San Francisco
Stanley A. Cohen, M.D., Principal Investigator, Affiliation: Children's Center for Digestive HealthCare, LLC


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Response, as defined by a reduction of the mCDAI score of >70 points by 4 weeks compared with baseline

Secondary outcome:

Rate of remission as defined by the decrease in mCDAI > 100 points and total mCDAI < 150 by 4 weeks

Rate of response as defined by a reduction in HBI to less than 5 by 4 weeks

Rate of remission as defined by the decrease in HBI to less than 3 by 4 weeks

Time to response and/or remission including time to change in HBI, according to elements of the daily patient diary

Rate of response as defined by the decrease in PCDAI of 12.5 points by 4 weeks

Rate of remission as defined by the decrease in PCDAI < 10 by 4 weeks

Change in IMPACT-III from baseline to 4 weeks

Change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary

Absence of night time stools, if they were present on entry, and time to disappearance

Time to normalization of all other components in the diary

Change in Hgb, ESR, CRP, platelet count, calprotectin from baseline and time to normalization

Change in global physician assessment of disease activity from baseline to study completion


Minimum age: 2 Years. Maximum age: 18 Years. Gender(s): Both.


Inclusion Criteria:

- Age less than 18 years

- Crohn's disease predominantly involving the ileum and/or cecum. The diagnosis must

have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist.

- Harvey Bradshaw Index of at least 7

- The onset of the acute flare should have been abrupt, declaring itself over 72 hours,

and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry.

- Written informed consent

Exclusion Criteria:

- Concomitant corticosteroids, budesonide

- Corticosteroids within 2 months

- Cyclosporine, mycophenolate mofetil or experimental drugs during the last three


- Maintenance infliximab, or infliximab or other biologics in the preceding 3 months

- If the severity of the flare has started to decrease spontaneously

- Coexisting diagnosis of primary sclerosing cholangitis

- Infectious diarrhea

- Signs of intestinal obstruction or perforation

- New fistulization as part of the acute flare or increased activity in chronic

fistula(e) as part of the acute flare

- Hypersensitivity to 4-ASA or any components of PASER®

- Pregnancy or breast-feeding

- Failure of a woman of child-bearing potential to agree to use adequate contraception

for the 4 week period of the trial, if sexually active

- Severe renal or hepatic disease (i. e., more than 3 times upper limit of normal) or a

WBC < 3,000 during the preceding three months

Locations and Contacts

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

University of California, San Francisco, San Francisco, California 94143-0316, United States

Children's Center for Digestive HealthCare, LLC, Atlanta, Georgia 30342, United States

Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital, Morristown, New Jersey 07962, United States

Texas Children's Hospital, Baylor College of Medicine, Houston, Texas 77030, United States

Additional Information

Starting date: June 2007
Last updated: October 19, 2011

Page last updated: August 23, 2015

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