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Efforts at recruitment have halted as recruitment was poor
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | 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 | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-Aminosalicylic acid extended release granules | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks |
| Rate of Response as Defined by a Reduction in HBI to Less Than 5 by 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David P Jacobus, MD | Jacobus Pharmaceutical | Study Chair |
| Kathy L Ales, MD | Jacobus Pharmaceutical | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| University of California, San Francisco |
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Recruitment was slow with only 2 patients entered.
The study was open to eligible patients under the care of or referred to investigators at 5 different academic medical centers from July 2007 through October 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | 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 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 4 weeks |
| Rate of Remission as Defined by the Decrease in HBI to Less Than 3 by 4 Weeks | 4 weeks |
| Time to Response and/or Remission Including Time to Change in HBI, According to Elements of the Daily Patient Diary | up to 4 weeks |
| Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks | 4 weeks |
| Rate of Remission as Defined by the Decrease in PCDAI < 10 by 4 Weeks | 4 weeks |
| Change in IMPACT-III From Baseline to 4 Weeks | 4 weeks |
| Change From Baseline in the Patient's General Sense of Disease Activity as Recorded in the Individual Daily Diary | 4 weeks |
| Absence of Night Time Stools, if They Were Present on Entry, and Time to Disappearance | up to 4 weeks |
| Time to Normalization of All Other Components in the Diary | up to 4 weeks |
| Change in Hgb, ESR, CRP, Platelet Count, Calprotectin From Baseline and Time to Normalization | 2 weeks and 4 weeks |
| Change in Global Physician Assessment of Disease Activity From Baseline to Study Completion | 4 weeks |
| San Francisco |
| California |
| 94143-0316 |
| United States |
| Children's Center for Digestive HealthCare, LLC | Atlanta | Georgia | 30342 | United States |
| Atlantic Health System / Morristown Memorial Hospital / Goryeb Children's Hospital | Morristown | New Jersey | 07962 | United States |
| Texas Children's Hospital, Baylor College of Medicine | Houston | Texas | 77030 | United States |
Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 4-Aminosalicylic Acid Extended Release Granules | 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 |
| BG001 | Placebo Granules | Oral granules administered as (volume equivalent of active product) 0 mg/kg three times daily for two weeks followed by (volume equivalent) 0 mg/kg two times daily for 2 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 4 weeks |
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| Secondary | 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 | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Rate of Response as Defined by a Reduction in HBI to Less Than 5 by 4 Weeks | Posted | 4 weeks |
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| Secondary | Rate of Remission as Defined by the Decrease in HBI to Less Than 3 by 4 Weeks | Posted | 4 weeks |
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| Secondary | Time to Response and/or Remission Including Time to Change in HBI, According to Elements of the Daily Patient Diary | Posted | up to 4 weeks |
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| Secondary | Rate of Response as Defined by the Decrease in PCDAI of 12.5 Points by 4 Weeks | Posted | 4 weeks |
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| Secondary | Rate of Remission as Defined by the Decrease in PCDAI < 10 by 4 Weeks | Posted | 4 weeks |
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| Secondary | Change in IMPACT-III From Baseline to 4 Weeks | Posted | 4 weeks |
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| Secondary | Change From Baseline in the Patient's General Sense of Disease Activity as Recorded in the Individual Daily Diary | Posted | 4 weeks |
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| Secondary | Absence of Night Time Stools, if They Were Present on Entry, and Time to Disappearance | Posted | up to 4 weeks |
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| Secondary | Time to Normalization of All Other Components in the Diary | Posted | up to 4 weeks |
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| Secondary | Change in Hgb, ESR, CRP, Platelet Count, Calprotectin From Baseline and Time to Normalization | Posted | 2 weeks and 4 weeks |
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| Secondary | Change in Global Physician Assessment of Disease Activity From Baseline to Study Completion | Posted | 4 weeks |
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Duration of treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | 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 | 0 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Placebo | 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 | 0 | 1 | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Probably related, resolved with change in vehicle of administration and decreased dose |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment | Unlikey to be related; resolved |
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| Worsening of disease, abdominal pain | Gastrointestinal disorders | Systematic Assessment | Occurred after the 4 week trial during continued off-study use |
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| Chest pain and headache | General disorders | Systematic Assessment | Related to introduction of flaxseed oil and resolved with discontinuation of flaxseed oil |
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| Dizziness after exercise | General disorders | Systematic Assessment | Occurred twice |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathy Aleš, Medical Director | Jacobus Pharmaceutical Company, Inc. | 609-921-7448 | 238 | kathy.ales@jacobus-pharmaceutical.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| C536215 | Pediatric Crohn's disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D010131 | Aminosalicylic Acid |
| ID | Term |
|---|---|
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
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| Male |
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