Trial | NCT00417690  Report issue

Title

High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease
A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    54
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.
Study Started
Jan 31
2007
Primary Completion
Dec 31
2007
Study Completion
Oct 31
2008
Last Update
Oct 15
2008
Estimate

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

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

A Experimental

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

P Placebo Comparator

One packet of oral granules administered three times daily for 2 weeks followed by one packet two times daily for two weeks

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
No Results Posted