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

Primary Purpose

Crohn's Disease

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

4-Aminosalicylic acid extended release granules

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring 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

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cedars-Sinai Medical Center
University of California, San Francisco
Children's Center for Digestive HealthCare, LLC
Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital
Texas Children's Hospital, Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT00495521

First Posted

June 29, 2007

Last Updated

August 23, 2017

Sponsor

Jacobus Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00495521

Brief Title

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

Official Title

A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Terminated

Why Stopped

Efforts at recruitment have halted as recruitment was poor

Study Start Date

June 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jacobus Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

4-Aminosalicylic acid extended release granules

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Reduction in the Modified Crohn's Disease Activity Index (mCDAI) Score of >70 Points by 4 Weeks Compared With Baseline

Description

Reduction in the Modified Crohn's Disease Activity Index (mCDAI) score of >70 points by 4 weeks after randomization compared with baseline

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Rate of Remission

Description

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

Time Frame

4 weeks

Title

Rate of Response as Defined by a Reduction in HBI to Less Than 5 by 4 Weeks

Time Frame

4 weeks

Title

Rate of Remission as Defined by the Decrease in HBI to Less Than 3 by 4 Weeks

Time Frame

4 weeks

Title

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

Title

Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks

Time Frame

4 weeks

Title

Rate of Remission as Defined by the Decrease in PCDAI < 10 by 4 Weeks

Time Frame

4 weeks

Title

Change in IMPACT-III From Baseline to 4 Weeks

Time Frame

4 weeks

Title

Change From Baseline in the Patient's General Sense of Disease Activity as Recorded in the Individual Daily Diary

Time Frame

4 weeks

Title

Absence of Night Time Stools, if They Were Present on Entry, and Time to Disappearance

Time Frame

up to 4 weeks

Title

Time to Normalization of All Other Components in the Diary

Time Frame

up to 4 weeks

Title

Change in Hgb, ESR, CRP, Platelet Count, Calprotectin From Baseline and Time to Normalization

Time Frame

2 weeks and 4 weeks

Title

Change in Global Physician Assessment of Disease Activity From Baseline to Study Completion

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: