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

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 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

Condition	Intervention	Phase
Crohn's Disease	Drug: 4-Aminosalicylic acid Drug: PASER placebo granules	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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: 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 CDAI 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 CDAI > 100 points and total CDAI < 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 ]
Increase in IBDQ to greater than 170 and the time to score above 170 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary [ Time Frame: up to 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:	January 2007
Study Completion Date:	October 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks	Drug: 4-Aminosalicylic acid Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks Other Names: PASER Granules NDC 49938-107-04
Placebo Comparator: P One packet of oral granules administered three times daily for 2 weeks followed by one packet two times daily for two weeks	Drug: PASER placebo granules Oral granules administered administered as one packet three times daily for two weeks followed by one packet two times daily for two weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-65
Crohn's disease involving predominantly 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, including budesonide
Corticosteroids within the previous 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
Change in dose during previous 4 weeks in 5-aminosalicylate, probiotic and/or antibiotic, or in chronic azathioprine, 6-mercaptopurine, or methotrexate
If currently using azathioprine, 6-mercaptopurine or methotrexate, these must have been used steadily for at least 4 months
Current experimental drugs or experimental drugs within the last 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 or abscess,
New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare,
Increased activity of pre-existing anal or rectal Crohn's disease as part of the flare
Allergy or sensitivity to salicylates
Pregnancy or breast-feeding
Failure of a woman of child-bearing age to agree to use adequate contraception for the 4 week period of the trial, if sexually active
Severe renal or hepatic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417690

Locations

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
United States, New York
Mount Sinai School of Medicine IBD Research Center
New York, New York, United States, 10028
United States, North Carolina
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States, 28207
Israel
Rambam Medical Center
Haifa, Israel, 31096
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239

Sponsors and Collaborators

Jacobus Pharmaceutical

Investigators

Study Chair:	David P. Jacobus, MD	Jacobus Pharmaceutical
Study Director:	Kathy L. Ales, MD	Jacobus Pharmaceutical
Principal Investigator:	Daniel Present, MD	Mount Sinai School of Medicine
Principal Investigator:	Stephen B. Hanauer, MD	University of Chicago Hospitals
Principal Investigator:	John Hanson, MD	Charlotte Gastroenterology & Hepatology, PLLC
Principal Investigator:	Iris Dotan, MD	Tel-Aviv Sourasky Medical Center
Principal Investigator:	Rami Eliakim, MD	Rambam Health Care Campus

More Information

No publications provided

Responsible Party:	Kathy Ales, MD Medical Director, Jacobus Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:	NCT00417690 History of Changes
Other Study ID Numbers:	PASER-AFC.001
Study First Received:	January 2, 2007
Last Updated:	October 14, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Jacobus Pharmaceutical:

Crohn's Disease
Acute Flare
Mild to moderate Crohn's Disease
Ileocecal distribution

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

Aminosalicylic Acid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013