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Sponsored by: |
Jacobus Pharmaceutical |
---|---|
Information provided by: | Jacobus Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00495521 |
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: PASER or placebo granules |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease |
Estimated Enrollment: | 54 |
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 |
---|---|
A: Experimental
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
|
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
|
P: Placebo Comparator
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
|
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
|
Ages Eligible for Study: | 2 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Responsible Party: | Jacobus Pharmaceutical Company, Inc. ( Kathy Ales, M.D. Medical Director ) |
Study ID Numbers: | PASER - AFC.002 |
Study First Received: | June 29, 2007 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00495521 |
Health Authority: | United States: Food and Drug Administration |
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 |
Crohn's disease Digestive System Diseases Gastrointestinal Diseases Ileitis P-Aminosalicylic Acid Enteritis |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases Ileal Diseases Crohns disease, pediatric |
Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Antitubercular Agents Pharmacologic Actions |