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

Condition(s) targeted: Crohn's Disease

Intervention: PASER or placebo granules (Drug)

Phase: Phase 2

Status: Recruiting

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

Overall contact:
Kathy L Ales, MD, Phone: 609-921-7447, Ext: 238, Email: kathy.ales@verizon.net

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.

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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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.

Criteria:

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

months

- 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

Kathy L Ales, MD, Phone: 609-921-7447, Ext: 238, Email: kathy.ales@verizon.net

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Marla C Dubinsky, MD, Phone: 310-423-2466, Email: marla.dubinsky@cshs.org
Elizabeth Vandenbogaart, Phone: 310-423-1686, Email: Elizabeth.Vandenbogaart@cshs.org
Marla C Dubinsky, MD, Principal Investigator

University of California, San Francisco, San Francisco, California 94143-0316, United States; Recruiting
Melvin B. Heyman, M.D., M.P.H., Phone: 415-476-5892, Email: mheyman@peds.ucsf.edu
Liz Garnett, Phone: 415-514-4423, Email: garnette@peds.ucsf.edu
Melvin B. Heyman, M.D., M.P.H., Principal Investigator

Children's Center for Digestive HealthCare, LLC, Atlanta, Georgia 30342, United States; Recruiting
Stanley A. Cohen, M.D., Phone: 404-503-0799, Email: stancohen@aol.com
Tamara Gobin, Phone: 404-503-2263, Email: tgobin@ccdhc.org
Stanley A. Cohen, M.D., Principal Investigator
Jeffrey A. Blumenthal, M.D., Sub-Investigator
Jay A. Hochman, M.D., Sub-Investigator
Jeffrey D. Lewis, M.D., Sub-Investigator
Larry G. Lewis, M.D., Sub-Investigator
Steven Liu, M.D., Sub-Investigator
William F. Meyers, M.D., Sub-Investigator
Dinesh Patel, M.D., Sub-Investigator
Edith A Schear Pilzer, M.D., Sub-Investigator
Larry M. Saripkin, M.D., Sub-Investigator
Olga M Bonilla Sherrod, M.D., Sub-Investigator

Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital, Morristown, New Jersey 07962, United States; Recruiting
Joel Rosh, MD, Phone: 973-971-5676, Email: joel.rosh@ahsys.org
Ruth Irizarry, Phone: 973-971-7591, Email: ruth.irizarry@atlantichealth.com
Joel R Rosh, MD, Principal Investigator
Tamara Feldman, MD, Sub-Investigator
Richard Mones, MD, Sub-Investigator
Stephanie Schuckalo, APN, Sub-Investigator
Barbara Verga, MD, Sub-Investigator
Peter Wilmot, MD, Sub-Investigator
Nader Youssef, MD, Sub-Investigator

Texas Children's Hospital, Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Caroyn H Thibodeaux, Phone: 832-822-3621
George D Ferry, MD, Phone: 832-822-3602, Email: gdferry@texaschildrenshospital.org
Douglas S Fishman, MD, Sub-Investigator
Mark A Gilger, MS, Sub-Investigator
G S Gopalakrishna, MD, Sub-Investigator
Craig Jensen, MD, Sub-Investigator
Seiji Kitagawa, MD, Sub-Investigator
Carlos Lifschitz, MD, Sub-Investigator
Kathleen Motil, MD, Sub-Investigator
Anthony Olive, MD, Sub-Investigator
Carol A Redel, MD, Sub-Investigator
Barbara S Reid, MD, Sub-Investigator
Nicole Rosipal, MD, Sub-Investigator
Bryan Vartabedian, MD, Sub-Investigator

Starting date: June 2007
Ending date: January 2011
Last updated: July 1, 2008