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

This study has been terminated.
(Efforts at recruitment have halted as recruitment was poor.)
Sponsor:
Information provided by:
Jacobus Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00417690
First received: January 2, 2007
Last updated: October 14, 2008
Last verified: October 2008

January 2, 2007
October 14, 2008
January 2007
December 2007   (final data collection date for primary outcome measure)
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 ]
Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline
Complete list of historical versions of study NCT00417690 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Rate of remission as defined by the decrease in CDAI > 100 points and total CDAI < 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
  • Increase in IBDQ to greater than 170 and the time to score above 170
  • The 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
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
  • 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
  • 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
    Intervention: Drug: 4-Aminosalicylic acid
  • 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
    Intervention: Drug: PASER placebo granules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
54
October 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel
 
NCT00417690
PASER-AFC.001
Not Provided
Kathy Ales, MD Medical Director, Jacobus Pharmaceutical Company, Inc.
Jacobus Pharmaceutical
Not Provided
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
Jacobus Pharmaceutical
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP