TerminatedNCT00417690Updated Oct 15, 2008

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

A Phase 2 interventional study of 4-Aminosalicylic acid and PASER placebo granules in Crohn's Disease, sponsored by Jacobus Pharmaceutical. Terminated at 5 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-10-15.

Sponsored by Jacobus Pharmaceutical · Phase 2, Interventional, and Treatment

Why this study was terminated

Efforts at recruitment have halted as recruitment was poor.

Phase: Phase 2
Study type: Interventional
Enrollment: 54
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Crohn's Disease

Browse trials for

Crohn Disease 1,880

Keywords

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

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 54 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Jacobus Pharmaceutical is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: 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

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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 54 participants (estimated)

Study arms

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
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

Interventions

Drug4-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
Also known as: PASER Granules, NDC 49938-107-04
DrugPASER 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

What researchers measure

Primary outcomes

Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline
Time frame: 4 weeks

Secondary outcomes

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

Study locations

5 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00417690
Lead sponsor: Jacobus Pharmaceutical
First posted: Jan 4, 2007
Start date: Jan 2007
Primary completion: Dec 2007
Completion: Oct 2008
Last update: Oct 15, 2008

Study contacts

David P. Jacobus, MD

study chair · Jacobus Pharmaceutical

Kathy L. Ales, MD

study director · Jacobus Pharmaceutical

Daniel Present, MD

principal investigator · Icahn School of Medicine at Mount Sinai

Stephen B. Hanauer, MD

principal investigator · University of Chicago Hospitals

John Hanson, MD

principal investigator · Charlotte Gastroenterology & Hepatology, PLLC

Iris Dotan, MD

principal investigator · Tel-Aviv Sourasky Medical Center

Rami Eliakim, MD

principal investigator · Rambam Health Care Campus

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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