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

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: NCT00495521
• Other study ID #: PASER - AFC.002
• Status: Terminated
• Phase: Phase 2
• First received: June 29, 2007
• Last updated: August 23, 2017
• Start date: June 2007
• Est. completion date: October 2008

Study information

• Verified date: August 2017
• Source: Jacobus Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• 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 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

Description:

Eligible pediatric patients with acute flares of ileocecal Crohn's disease will be randomized to receive either PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, or an identical-appearing placebo preparation.

Patients will be required to maintain a daily diary and to return at 2 weeks for blood and stool tests. At the four week mark, patients will return for clinical evaluation, global assessment of disease activity and change in disease activity, as well as additional laboratory tests.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age less than 18 years

• Crohn's disease predominantly involving 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, budesonide

• Corticosteroids within 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

• 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

• New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare

• Hypersensitivity to 4-ASA or any components of PASER®

• Pregnancy or breast-feeding

• Failure of a woman of child-bearing potential to agree to use adequate contraception for the 4 week period of the trial, if sexually active

• Severe renal or hepatic disease (i.e., more than 3 times upper limit of normal) or a WBC < 3,000 during the preceding three months

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• 4-Aminosalicylic acid extended release granules
Granules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm

Locations

Country	Name	City	State
United States	Children's Center for Digestive HealthCare, LLC	Atlanta	Georgia
United States	Texas Children's Hospital, Baylor College of Medicine	Houston	Texas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital	Morristown	New Jersey
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Jacobus Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline	Reduction in the Modified Crohn's Disease Activity Index (mCDAI) score of >70 points by 4 weeks after randomization compared with baseline	4 weeks
Secondary	Rate of Remission	Rate of remission was defined by a decrease in modified Crohn's Disease Activity Index (mCDAI) > 100 points and total mCDAI < 150 by 4 weeks	4 weeks
Secondary	Rate of Response as Defined by a Reduction in HBI to Less Than 5 by 4 Weeks		4 weeks
Secondary	Rate of Remission as Defined by the Decrease in HBI to Less Than 3 by 4 Weeks		4 weeks
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
Secondary	Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks		4 weeks
Secondary	Rate of Remission as Defined by the Decrease in PCDAI < 10 by 4 Weeks		4 weeks
Secondary	Change in IMPACT-III From Baseline to 4 Weeks		4 weeks
Secondary	Change From Baseline in the Patient's General Sense of Disease Activity as Recorded in the Individual Daily Diary		4 weeks
Secondary	Absence of Night Time Stools, if They Were Present on Entry, and Time to Disappearance		up to 4 weeks
Secondary	Time to Normalization of All Other Components in the Diary		up to 4 weeks
Secondary	Change in Hgb, ESR, CRP, Platelet Count, Calprotectin From Baseline and Time to Normalization		2 weeks and 4 weeks
Secondary	Change in Global Physician Assessment of Disease Activity From Baseline to Study Completion		4 weeks