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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 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks |
|
| P | Placebo Comparator | One packet of oral granules administered three times daily for 2 weeks followed by one packet two times daily for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-Aminosalicylic acid | Drug | Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of remission as defined by the decrease in CDAI > 100 points and total CDAI < 150 by 4 weeks | 4 weeks | |
| Rate of response as defined by a reduction in HBI to less than 5 by 4 weeks | 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 |
| Daniel Present, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Stephen B. Hanauer, MD | University of Chicago Hospitals | Principal Investigator |
| John Hanson, MD | Charlotte Gastroenterology & Hepatology, PLLC | Principal Investigator |
| Iris Dotan, MD | Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Rami Eliakim, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States | ||
| Mount Sinai School of Medicine IBD Research Center |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010131 | Aminosalicylic Acid |
| ID | Term |
|---|---|
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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|
| PASER placebo granules | Drug | Oral granules administered administered as one packet three times daily for two weeks followed by one packet two times daily for two 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 |
| Increase in IBDQ to greater than 170 and the time to score above 170 | 4 weeks |
| The change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary | up to 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 |
| New York |
| New York |
| 10028 |
| United States |
| Charlotte Gastroenterology and Hepatology, PLLC | Charlotte | North Carolina | 28207 | United States |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Tel-Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| D007410 | Intestinal Diseases |
| 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 |