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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00417690
Recruitment Status : Terminated (Efforts at recruitment have halted as recruitment was poor.)
First Posted : January 4, 2007
Last Update Posted : October 15, 2008
Information provided by:
Jacobus Pharmaceutical

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Rate of remission as defined by the decrease in CDAI > 100 points and total CDAI < 150 by 4 weeks [ Time Frame: 4 weeks ]
  2. Rate of response as defined by a reduction in HBI to less than 5 by 4 weeks [ Time Frame: 4 weeks ]
  3. Rate of remission as defined by the decrease in HBI to less than 3 by 4 weeks [ Time Frame: 4 weeks ]
  4. 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 ]
  5. Increase in IBDQ to greater than 170 and the time to score above 170 [ Time Frame: 4 weeks ]
  6. 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 ]
  7. Absence of night time stools, if they were present on entry, and time to disappearance [ Time Frame: up to 4 weeks ]
  8. Time to normalization of all other components in the diary [ Time Frame: up to 4 weeks ]
  9. Change in Hgb, ESR, CRP, platelet count, calprotectin from baseline and time to normalization [ Time Frame: 2 weeks and 4 weeks ]
  10. Change in global physician assessment of disease activity from baseline to study completion [ Time Frame: 4 weeks ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00417690

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
Rambam Medical Center
Haifa, Israel, 31096
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Jacobus Pharmaceutical
Study Chair: David P. Jacobus, MD Jacobus Pharmaceutical
Study Director: Kathy L. Ales, MD Jacobus Pharmaceutical
Principal Investigator: Daniel Present, MD Icahn School of Medicine at Mount Sinai
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

Responsible Party: Kathy Ales, MD Medical Director, Jacobus Pharmaceutical Company, Inc. Identifier: NCT00417690     History of Changes
Other Study ID Numbers: PASER-AFC.001
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: October 2008

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
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Aminosalicylic Acid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents