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

Sponsor:	Jacobus Pharmaceutical
Information provided by:	Jacobus Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00495521

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	Drug: PASER or placebo granules	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: p-Aminosalicylic acid

U.S. FDA Resources

Further study details as provided by Jacobus Pharmaceutical:

Primary Outcome Measures:

Response, as defined by a reduction of the mCDAI score of >70 points by 4 weeks compared with baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of remission as defined by the decrease in mCDAI > 100 points and total mCDAI < 150 by 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Rate of response as defined by a reduction in HBI to less than 5 by 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Rate of remission as defined by the decrease in HBI to less than 3 by 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Time to response and/or remission including time to change in HBI, according to elements of the daily patient diary [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
Rate of response as defined by the decrease in PCDAI of 12.5 points by 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Rate of remission as defined by the decrease in PCDAI < 10 by 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change in IMPACT-III from baseline to 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Absence of night time stools, if they were present on entry, and time to disappearance [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
Time to normalization of all other components in the diary [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
Change in Hgb, ESR, CRP, platelet count, calprotectin from baseline and time to normalization [ Time Frame: 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
Change in global physician assessment of disease activity from baseline to study completion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	54
Study Start Date:	June 2007
Study Completion Date:	October 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks	Drug: PASER or placebo granules Granules for oral administration 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 amount in the placebo arm
P: Placebo Comparator Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks	Drug: PASER or placebo granules Granules for oral administration 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 amount in the placebo arm

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495521

Locations

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, San Francisco
San Francisco, California, United States, 94143-0316
United States, Georgia
Children's Center for Digestive HealthCare, LLC
Atlanta, Georgia, United States, 30342
United States, New Jersey
Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital
Morristown, New Jersey, United States, 07962
United States, Texas
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

Jacobus Pharmaceutical

Investigators

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

More Information

No publications provided

Responsible Party:	Jacobus Pharmaceutical Company, Inc. ( Kathy Ales, M.D. Medical Director )
Study ID Numbers:	PASER - AFC.002
Study First Received:	June 29, 2007
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00495521 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Jacobus Pharmaceutical:

Crohn's
Crohn's Disease
Acute Flare
Mild to Moderate Crohn's Disease
Children

Pediatrics
Ileo-cecal
Pediatric Crohn's Disease
New Onset Crohn's Disease
Recently diagnosed Crohn's Disease

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
P-Aminosalicylic Acid

Crohn Disease
Inflammatory Bowel Diseases
Antitubercular Agents
Intestinal Diseases
Gastroenteritis
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009