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

This study has been terminated.
(Efforts at recruitment have halted as recruitment was poor)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00495521
First Posted: July 3, 2007
Last Update Posted: September 21, 2017
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.
Information provided by (Responsible Party):
Jacobus Pharmaceutical
  Purpose
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.

Condition Intervention Phase
Crohn's Disease Drug: 4-Aminosalicylic acid extended release granules Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jacobus Pharmaceutical:

Primary Outcome Measures:
  • Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline [ Time Frame: 4 weeks ]
    Reduction in the Modified Crohn's Disease Activity Index (mCDAI) score of >70 points by 4 weeks after randomization compared with baseline


Secondary Outcome Measures:
  • Rate of Remission [ Time Frame: 4 weeks ]
    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

  • 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 ]
  • Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks [ Time Frame: 4 weeks ]
  • Rate of Remission as Defined by the Decrease in PCDAI < 10 by 4 Weeks [ Time Frame: 4 weeks ]
  • Change in IMPACT-III From Baseline to 4 Weeks [ Time Frame: 4 weeks ]
  • Change From Baseline in the Patient's General Sense of Disease Activity as Recorded in the Individual Daily Diary [ Time Frame: 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 ]

Enrollment: 2
Study Start Date: June 2007
Study Completion Date: October 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Other Names:
  • PASER® Granules (or Placebo Granules)
  • 4-Aminosalicylic acid
  • NDC 49938-107-04
  • 4-ASA
Placebo Comparator: 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
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
Other Names:
  • PASER® Granules (or Placebo Granules)
  • 4-Aminosalicylic acid
  • NDC 49938-107-04
  • 4-ASA

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00495521


Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, San Francisco
San Francisco, California, United States, 94143-0316
United States, Georgia
Children's Center for Digestive HealthCare, LLC
Atlanta, Georgia, United States, 30342
United States, New Jersey
Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital
Morristown, New Jersey, United States, 07962
United States, Texas
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Jacobus Pharmaceutical
Investigators
Study Chair: David P Jacobus, MD Jacobus Pharmaceutical
Study Director: Kathy L Ales, MD Jacobus Pharmaceutical
Principal Investigator: George D Ferry, MD Texas Children's Hospital, Baylor College of Medicine
Principal Investigator: Marla C Dubinsky, MD Cedars-Sinai Medical Center
Principal Investigator: Joel R Rosh, MD Atlantic Health System, Morristown General Hospital, Goryeb Children's Hospital
Principal Investigator: Melvin B. Heyman, M.D., M.P.H. University of California, San Francisco
Principal Investigator: Stanley A. Cohen, M.D. Children's Center for Digestive Healthcare, LLC
  More Information

Responsible Party: Jacobus Pharmaceutical
ClinicalTrials.gov Identifier: NCT00495521     History of Changes
Other Study ID Numbers: PASER - AFC.002
First Submitted: June 29, 2007
First Posted: July 3, 2007
Results First Submitted: June 5, 2017
Results First Posted: September 21, 2017
Last Update Posted: September 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jacobus Pharmaceutical:
Crohn's
Crohn's Disease
Acute Flare
Mild to Moderate Crohn's Disease
Children
Pediatrics
Ileo-cecal
Pediatric Crohn's Disease
New Onset Crohn's Disease
Recently diagnosed Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Aminosalicylic Acid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents