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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:
Information provided by (Responsible Party):
Jacobus Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00495521
First received: June 29, 2007
Last updated: October 19, 2011
Last verified: October 2011

June 29, 2007
October 19, 2011
June 2007
July 2008   (final data collection date for primary outcome measure)
Response, as defined by a reduction of the mCDAI score of >70 points by 4 weeks compared with baseline [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Response, as defined by a reduction of the mCDAI score of >70 points by 4 weeks compared with baseline
Complete list of historical versions of study NCT00495521 on ClinicalTrials.gov Archive Site
  • Rate of remission as defined by the decrease in mCDAI > 100 points and total mCDAI < 150 by 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Rate of response as defined by a reduction in HBI to less than 5 by 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Rate of remission as defined by the decrease in HBI to less than 3 by 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Rate of response as defined by the decrease in PCDAI of 12.5 points by 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Rate of remission as defined by the decrease in PCDAI < 10 by 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in IMPACT-III from baseline to 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Absence of night time stools, if they were present on entry, and time to disappearance [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Time to normalization of all other components in the diary [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
  • Change in Hgb, ESR, CRP, platelet count, calprotectin from baseline and time to normalization [ Time Frame: 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
  • Change in global physician assessment of disease activity from baseline to study completion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Rate of remission as defined by the decrease in 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
  • Rate of remission as defined by the decrease in HBI to less than 3 by 4 weeks
  • Time to response and/or remission including time to change in HBI, according to elements of the daily patient diary
  • Rate of response as defined by the decrease in PCDAI of 12.5 points by 4 weeks
  • Rate of remission as defined by the decrease in PCDAI < 10 by 4 weeks
  • Change in IMPACT-III from baseline to 4 weeks
  • Change from baseline in the patient’s general sense of disease activity as recorded in the individual daily diary
  • Absence of night time stools, if they were present on entry, and time to disappearance
  • Time to normalization of all other components in the diary
  • Change in Hgb, ESR, CRP, platelet count, calprotectin from baseline and time to normalization
  • Change in global physician assessment of disease activity from baseline to study completion
Not Provided
Not Provided
 
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children
A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
Drug: PASER or placebo granules
Granules for oral administration 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 amount in the placebo arm
Other Names:
  • PASER Granules (or Placebo Granules)
  • 4-Aminosalicylic acid
  • NDC 49938-107-04
  • Experimental: A
    Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
    Intervention: Drug: PASER or placebo granules
  • Placebo Comparator: P
    Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
    Intervention: Drug: PASER or placebo granules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
October 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00495521
PASER - AFC.002
No
Jacobus Pharmaceutical
Jacobus Pharmaceutical
Not Provided
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
Jacobus Pharmaceutical
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP