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

NCT ID: NCT00495521

Last Updated: 2017-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-10-31

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 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.

Detailed 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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

4-Aminosalicylic acid extended release granules (as volume equivalent of active product), 50 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 50 mg/kg orally two times daily for 2 weeks

Group Type: EXPERIMENTAL

4-Aminosalicylic acid extended release granules

Intervention Type: DRUG

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

Placebo

Placebo granules identical in appearance to the active arm (as volume equivalent of active product), 0 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 0 mg/kg orally two times daily for 2 weeks

Group Type: PLACEBO_COMPARATOR

4-Aminosalicylic acid extended release granules

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

PASER® Granules (or Placebo Granules); 4-Aminosalicylic acid; NDC 49938-107-04; 4-ASA

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jacobus Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David P Jacobus, MD

Role: STUDY_CHAIR

Jacobus Pharmaceutical

Kathy L Ales, MD

Role: STUDY_DIRECTOR

Jacobus Pharmaceutical

George D Ferry, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Children's Hospital, Baylor College of Medicine

Marla C Dubinsky, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Joel R Rosh, MD

Role: PRINCIPAL_INVESTIGATOR

Atlantic Health System, Morristown General Hospital, Goryeb Children's Hospital

Melvin B. Heyman, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Stanley A. Cohen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Center for Digestive Healthcare, LLC

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Children's Center for Digestive HealthCare, LLC

Atlanta, Georgia, United States

Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital

Morristown, New Jersey, United States

Texas Children's Hospital, Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

PASER - AFC.002

Identifier Type: -

Identifier Source: org_study_id