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The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | mesalamine 2.4 g/day (400 mg tablet) for 6 weeks |
|
| 2 | Experimental | mesalamine 4.8 g/day (800 mg tablet) for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesalamine | Drug | mesalamine 2.4 g/day (400 mg tablet) for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Classified as Treatment Success at Week 6, ITT Population | Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Classified as Treatment Success at Week 3, ITT Population | Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery Kralstein, MD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21385195 | Derived | Orchard TR, van der Geest SA, Travis SP. Randomised clinical trial: early assessment after 2 weeks of high-dose mesalazine for moderately active ulcerative colitis - new light on a familiar question. Aliment Pharmacol Ther. 2011 May;33(9):1028-35. doi: 10.1111/j.1365-2036.2011.04620.x. Epub 2011 Mar 8. | |
| 21255059 | Derived |
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Screening began 9 Feb 2001
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| ID | Title | Description |
|---|---|---|
| FG000 | Asacol 2.4 g/Day | 2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks |
| FG001 | Asacol 4.8 g/Day | 2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| mesalamine |
| Drug |
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks |
|
| 3 weeks |
| Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients | PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as either complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse. | Week 3 |
| Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients | PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse. | Week 6 |
| Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage) | 0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse. | Week 3 |
| Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage) | 0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse. | Week 6 |
| Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage) | 0: no blood seen, 1: streaks of blood with stool less than half of the time, 2: obvious blood with stool most of the time, 3: blood alone passed, Scoring Scale: 0-good thru 3-worse. | Week 3 |
| Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage) | 0-no blood seen, 1- streaks of blood with stool less than half of the time, 2- obvious blood with stool most of the time, 3- blood alone passed. Scoring Scale: 0-good thru 3-worse. | Week 6 |
| Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage) | 0-generally well, 1-fair, 2-poor, 3-terrible | Week 3 |
| Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage) | 0-generally well, 1-fair, 2-poor, 3-terrible | Week 6 |
| Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage) | 0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse. | Week 3 |
| Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage) | 0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse. | Week 6 |
| Anaheim |
| California |
| United States |
| Research Site | Sacramento | California | United States |
| Research Site | San Francisco | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Facility | Golden | Colorado | United States |
| Research Site | Bridgeport | Connecticut | United States |
| Research Site | Fort Myers | Florida | United States |
| Research Site | Hollywood | Florida | United States |
| Research Site | Jupiter | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Facility | Atlanta | Georgia | United States |
| Research Facility | Decatur | Georgia | United States |
| Research Site | Arlington Heights | Illinois | United States |
| Research Site | Moline | Illinois | United States |
| Research Site | Rockford | Illinois | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Metairie | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Laurel | Maryland | United States |
| Research Site | Detroit | Michigan | United States |
| Research Site | New Brunswick | New Jersey | United States |
| Research Site | Somerville | New Jersey | United States |
| Research Site | Great Neck | New York | United States |
| Research Site | Pomona | New York | United States |
| Research Facility | Poughkeepsie | New York | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Winston-Salem | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Tulsa | Oklahoma | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Pittsburgh | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Facility | Memphis | Tennessee | United States |
| Research Facility | Nashville | Tennessee | United States |
| Research Site | Fort Worth | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Burlington | Vermont | United States |
| Research Site | Charlottesville | Virginia | United States |
| Research Facility | Falls Church | Virginia | United States |
| Research Site | Norfolk | Virginia | United States |
| Research Site | Tacoma | Washington | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| Lichtenstein GR, Ramsey D, Rubin DT. Randomised clinical trial: delayed-release oral mesalazine 4.8 g/day vs. 2.4 g/day in endoscopic mucosal healing--ASCEND I and II combined analysis. Aliment Pharmacol Ther. 2011 Mar;33(6):672-8. doi: 10.1111/j.1365-2036.2010.04575.x. Epub 2011 Jan 23. |
| ITT Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Asacol 2.4 g/Day | 2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks |
| BG001 | Asacol 4.8 g/Day | 2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 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, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Partcipants |
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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 | Percentage of Patients Classified as Treatment Success at Week 6, ITT Population | Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse. | ITT Population | Posted | Number | Percentage of Participants | 6 weeks |
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| Secondary | Percentage of Patients Classified as Treatment Success at Week 3, ITT Population | Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse. | ITT Population | Posted | Number | Percentage of Participants | 3 weeks |
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| Secondary | Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients | PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as either complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse. | All Randomized Patients | Posted | Number | Percentage of Participants | Week 3 |
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| Secondary | Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients | PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse. | All Randomized Patients | Posted | Number | Percentage of Participants | Week 6 |
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| Secondary | Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage) | 0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse. | All Randomized Patients | Posted | Number | Percentage of Participants | Week 3 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage) | 0: normal stool frequency per day, 1: 1-2 stools greater than normal per day, 2: 3-4 stools greater than normal per day, 3: 5 or more stools greater than normal per day, Scoring Scale: 0-good thru 3-worse. | All Randomized Patients | Posted | Number | Percentage of Participants | Week 6 |
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| Secondary | Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage) | 0: no blood seen, 1: streaks of blood with stool less than half of the time, 2: obvious blood with stool most of the time, 3: blood alone passed, Scoring Scale: 0-good thru 3-worse. | All Randomized Patients | Posted | Number | Percentage of Participants | Week 3 |
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| Secondary | Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage) | 0-no blood seen, 1- streaks of blood with stool less than half of the time, 2- obvious blood with stool most of the time, 3- blood alone passed. Scoring Scale: 0-good thru 3-worse. | All Randomized Patients | Posted | Number | Percentage of Participants | Week 6 |
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| Secondary | Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage) | 0-generally well, 1-fair, 2-poor, 3-terrible | All Randomized Patients | Posted | Number | Percentage of Participants | Week 3 |
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| Secondary | Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage) | 0-generally well, 1-fair, 2-poor, 3-terrible | All Randomized Patients | Posted | Number | Percentage of Participants | Week 6 |
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| Secondary | Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage) | 0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse. | All Randomized Patients | Posted | Number | Percentage of Participants | Week 3 |
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| Secondary | Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage) | 0-normal (intact vascular pattern, no friability or granularity), 1-mild (erythema; diminished or absent vascular markings; mild granularity; friability), 2-moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations), 3-severe (spontaneous bleeding, ulcerations). Scoring Scale: 0-good thru 3-worse. | All Randomized Patients | Posted | Number | Percentage of Participants | Week 6 |
|
|
6 week treatment period
Screening started February 2001, study completed November 2002
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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 | Asacol 2.4 g/Day | 2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks | 3 | 154 | 56 | 154 | ||
| EG001 | Asacol 4.8 g/Day | 2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks | 1 | 147 | 48 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uterine Fibroids Exacerbation | Reproductive system and breast disorders | COSTART | Systematic Assessment |
| |
| Ovarian Cyst Exacerbation | Reproductive system and breast disorders | COSTART | Systematic Assessment |
| |
| Worsening of Ulcerative Colitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
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| Rectal Bleeding | Gastrointestinal disorders | COSTART | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | COSTART | Systematic Assessment |
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| Abdominal Pain, Left Side | Vascular disorders | COSTART | Systematic Assessment |
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| Cholecystitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
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| Pain, Right Upper Quadrant | Nervous system disorders | COSTART | Systematic Assessment |
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| Epigastric Pain | Nervous system disorders | COSTART | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | COSTART | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | COSTART | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | COSTART | Systematic Assessment |
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| Infection | Infections and infestations | COSTART | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | COSTART | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | COSTART | Systematic Assessment |
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| Colitis Ulcer | Gastrointestinal disorders | COSTART | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | COSTART | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
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| Dizziness | Nervous system disorders | COSTART | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | COSTART | Systematic Assessment |
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| Flu Syndrome | Infections and infestations | COSTART | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan Wulff, Manager Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D062368 | meta-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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| Title | Measurements |
|---|---|
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| Male |
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| Black or African American |
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| Asian (Indian) |
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| Asian (Oriental) |
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| Hispanic |
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| Multi-racial/other |
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