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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
June 29, 2007
July 3, 2007
June 5, 2017
September 21, 2017
September 21, 2017
June 2007
July 2008   (Final data collection date for primary outcome measure)
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
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 [ 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 ]
  • 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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
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
  • 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
    Intervention: Drug: 4-Aminosalicylic acid extended release granules
  • 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
    Intervention: Drug: 4-Aminosalicylic acid extended release 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
Sexes Eligible for Study: All
2 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
Israel
 
NCT00495521
PASER - AFC.002
No
Not Provided
Plan to Share IPD: 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
August 2017

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