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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00417690
• Other study ID #: PASER-AFC.001
• Status: Terminated
• Phase: Phase 2
• First received: January 2, 2007
• Last updated: October 14, 2008
• Start date: January 2007
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: Jacobus Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: October 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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
• 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

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv
United States	Charlotte Gastroenterology and Hepatology, PLLC	Charlotte	North Carolina
United States	The University of Chicago	Chicago	Illinois
United States	Mount Sinai School of Medicine IBD Research Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Jacobus Pharmaceutical

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline		4 weeks	No
Secondary	Rate of remission as defined by the decrease in CDAI > 100 points and total CDAI < 150 by 4 weeks		4 weeks	No
Secondary	Rate of response as defined by a reduction in HBI to less than 5 by 4 weeks		4 weeks	No
Secondary	Rate of remission as defined by the decrease in HBI to less than 3 by 4 weeks		4 weeks	No
Secondary	Time to response and/or remission including time to change in HBI, according to elements of the daily patient diary		up to 4 weeks	No
Secondary	Increase in IBDQ to greater than 170 and the time to score above 170		4 weeks	No
Secondary	The change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary		up to 4 weeks	No
Secondary	Absence of night time stools, if they were present on entry, and time to disappearance		up to 4 weeks	No
Secondary	Time to normalization of all other components in the diary		up to 4 weeks	No
Secondary	Change in Hgb, ESR, CRP, platelet count, calprotectin from baseline and time to normalization		2 weeks and 4 weeks	No
Secondary	Change in global physician assessment of disease activity from baseline to study completion		4 weeks	No