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This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asacol 2.4 g/day | Active Comparator | Asacol (2.4 g/day) |
|
| Asacol 4.8 g/day | Experimental | Asacol (4.8 g/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asacol 800 mg (mesalamine) | Drug | tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population | Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments) | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population | UCDAI - sum of clinical assessment scores (stool frequency score [0=normal, 1=1-2 stools > normal/day, 2=3-4 stools > normal/day, 3=5 or more stools > normal/day], rectal bleeding score [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 and PGA score [0=quiescent disease, 1=mild, 2=moderate, 3=severe]) and sigmoidoscopy score [0=normal, 1=mild, 2=moderate, 3=severe]](streamdown:incomplete-link) |
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Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from admission to the study if they have/are:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Krzeski, MD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| AGMG Clinical Research |
| 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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Recruitment began Feb. 28, 2001. Randomized 386 patients of which 117 had mild disease and 268 had moderate disease at baseline. Analysis only includes patients with moderate disease at baseline.
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| ID | Title | Description |
|---|---|---|
| FG000 | Asacol 2.4 g/Day | Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening). |
| FG001 | Asacol 4.8 g/Day | Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Asacol 400 mg (mesalamine) | Drug | tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily |
|
| 6 weeks |
| Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population | Rectal Bleeding - 0=no blood seen, 1=streaks of blood w/stool less than half of the time, 2=obvious blood w/stool most of the time, 3=blood alone passed Sigmoidoscopy Assessment Score - 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) | 6 Weeks |
| Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population | Sigmoidoscopy Assessment Score (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) | 6 Weeks |
| Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6 | 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 | 6 Weeks |
| Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6 | Rectal Bleeding (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) | 6 Weeks |
| Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6 | PFA - 0=generally well, 1=fair, 2=poor, 3=terrible | 6 Weeks |
| Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6 | PGA -Physician's Global Assessment - 0=quiescent disease (all parameters 0), 1=mild disease (parameters mostly 1's) 2=moderate (parameters mostly 2's), 3=severe (parameters mostly 3's) [parameters: combination of stool frequency, rectal bleeding, PFA & sigmoidoscopy findings] If scoring equal default to physician judgement. | 6 Weeks |
| Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients | IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32 - 224 - higher score better. | 3 Weeks |
| Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients | IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32-224 - higher score better. | 6 Weeks |
| Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients | Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments) | 6 Weeks |
| Percentage of Treatment Success Patients at Week 3, ITT Population | Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments) | 3 Weeks |
| Anaheim |
| California |
| 92801 |
| United States |
| Research Site | Los Angeles | California | 90067 | United States |
| Community Clinical Trials | Orange | California | 38305 | United States |
| AGMG Clinical Research | Orange | California | 92869 | United States |
| Research Site | Sacramento | California | 95825 | United States |
| Sharp Rees-Stealy Medical Group | San Diego | California | 92123 | United States |
| Research Site | Arvada | Colorado | 80002 | United States |
| Research Site | Englewood | Colorado | 80110 | United States |
| Center for Medical Research, LLC | Manchester | Connecticut | 06040 | United States |
| Center for GI Disorders | Hollywood | Florida | 33021 | United States |
| Research Site | Maitland | Florida | 32789 | United States |
| Advanced Gastroenterology Associates | Palm Harbor | Florida | 34684 | United States |
| Research Site | Zephyrhills | Florida | 33540 | United States |
| Southeast Research Associates | Marietta | Georgia | 30067 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| GI Research | Metairie | Louisiana | 70001 | United States |
| Louisiana Research Center | Shreveport | Louisiana | 71103 | United States |
| Digestive Disorders Associates | Annapolis | Maryland | 21401 | United States |
| Research Site | Baltimore | Maryland | 21215 | United States |
| Digestive Disease Associates | Baltimore | Maryland | 21229 | United States |
| Metropolitan Gastroenterology Group | Chevy Chase | Maryland | 20815 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PharmaTrials, Inc. | Hillsborough | New Jersey | 08844 | United States |
| Research Site | Forest Hills | New York | 11375 | United States |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | United States |
| Research Site | New York | New York | 10128 | United States |
| Carolinas Digestive Health Associates | Charlotte | North Carolina | 28262 | United States |
| Research Site | Raleigh | North Carolina | 27612 | United States |
| Research Site | Statesville | North Carolina | 28677 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| Research Site | Cincinnati | Ohio | 45267 | United States |
| Research Site | Columbus | Ohio | 43215 | United States |
| GI & Liver Consultants | Dayton | Ohio | 45440 | United States |
| Research Site | Oklahoma City | Oklahoma | 73190 | United States |
| Research Site | Tulsa | Oklahoma | 74135 | United States |
| West Hills Gastroenterology Group | Portland | Oregon | 97225 | United States |
| Research Site | Altoona | Pennsylvania | 16602 | United States |
| Research Site | Hanover | Pennsylvania | 17331 | United States |
| Regional Research Institute | Jackson | Tennessee | 38305 | United States |
| Research Site | Austin | Texas | 78705 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Houston Medical Research Associates | Houston | Texas | 77090 | United States |
| Research Site | Temple | Texas | 76508 | United States |
| Research Site | Ogden | Utah | 84405 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22902 | United States |
| Research Site | Fairfax | Virginia | 22031 | United States |
| Research Site | Fredericksburg | Virginia | 22401 | United States |
| Richmond GI Research | Richmond | Virginia | 23226 | United States |
| Research Site | Spokane | Washington | 99207 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53207 | United States |
| Research Site | Richmond | British Columbia | V7C 5L9 | Canada |
| Research Site | Toronto | Ontario | M5B 1W8 | Canada |
| University of Puerto Rico, School of Medicine | San Juan | 00935 | Puerto Rico |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Asacol 2.4 g/Day | Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening). |
| BG001 | Asacol 4.8 g/Day | Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | All Randomized Patients with Moderate Disease [PGA (Physician's Global Assessment) = 2] at Baseline | Number | Participants |
| ||||||||||||||||||
| Sex: Female, Male | All Randomized Patients with Moderate Disease [PGA = 2] at Baseline | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | All Randomized Patients with Moderate Disease [PGA = 2] at Baseline | Number | Participants |
|
| 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 Treatment Success Patients at Week 6, ITT (Intent to Treat) Population | Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments) | ITT Population with Moderate Disease [PGA = 2] at Baseline | Posted | Number | Percentage of Participants | 6 Weeks |
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| Secondary | Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population | UCDAI - sum of clinical assessment scores (stool frequency score [0=normal, 1=1-2 stools > normal/day, 2=3-4 stools > normal/day, 3=5 or more stools > normal/day], rectal bleeding score [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 and PGA score [0=quiescent disease, 1=mild, 2=moderate, 3=severe]) and sigmoidoscopy score [0=normal, 1=mild, 2=moderate, 3=severe]](streamdown:incomplete-link) | ITT Population with Moderate Disease [PGA = 2] at Baseline. | Posted | Mean | Standard Error | Scores on a Scale | 6 weeks |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population | Rectal Bleeding - 0=no blood seen, 1=streaks of blood w/stool less than half of the time, 2=obvious blood w/stool most of the time, 3=blood alone passed Sigmoidoscopy Assessment Score - 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) | ITT Patients with Moderate Disease [PGA=2] at Baseline. Percentage of patients whose rectal bleeding AND sigmoidoscopy scores BOTH improved from baseline at Week 6 | Posted | Number | Percentage of Participants | 6 Weeks |
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| Secondary | Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population | Sigmoidoscopy Assessment Score (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) | ITT Population with Moderate Disease [PGA=2] at Baseline | Posted | Number | Percentage of Participants | 6 Weeks |
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| Secondary | Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6 | 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 | ITT Patients with Moderate Disease [PGA=2] at Baseline | Posted | Number | Percentage of Participants | 6 Weeks |
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| Secondary | Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6 | Rectal Bleeding (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) | ITT Population with Moderate Disease [PGA=2] at Baseline | Posted | Number | Percentage of Participants | 6 Weeks |
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| Secondary | Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6 | PFA - 0=generally well, 1=fair, 2=poor, 3=terrible | ITT Population with Moderate Disease [PGA=2] at Baseline | Posted | Number | Percentage of Participants | 6 Weeks |
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| Secondary | Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6 | PGA -Physician's Global Assessment - 0=quiescent disease (all parameters 0), 1=mild disease (parameters mostly 1's) 2=moderate (parameters mostly 2's), 3=severe (parameters mostly 3's) [parameters: combination of stool frequency, rectal bleeding, PFA & sigmoidoscopy findings] If scoring equal default to physician judgement. | ITT Population with Moderate Disease [PGA=2] at Baseline | Posted | Number | Percentage of Participants | 6 Weeks |
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| Secondary | Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients | IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32 - 224 - higher score better. | All Randomized Patients with Moderate Disease[PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social. | Posted | Mean | Standard Error | Scores on a Scale | 3 Weeks |
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| Secondary | Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients | IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32-224 - higher score better. | All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social. | Posted | Mean | Standard Error | Scores on a Scale | 6 Weeks |
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| Secondary | Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients | Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments) | All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Left Sided Disease = proctitis, proctosigmoiditis or left-sided colitis | Posted | Number | Percentage of Participants | 6 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Treatment Success Patients at Week 3, ITT Population | Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments) | ITT Patients with Moderate Disease [PGA = 2] at Baseline | Posted | Number | Percentage of Participants | 3 Weeks |
|
|
6 week treatment period for each subject, February 28, 2001 thru April 15 2004
Not provided
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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 | Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening). | 4 | 139 | 72 | 195 | ||
| EG001 | Asacol 4.8 g/Day | Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening). | 1 | 129 | 81 | 191 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | COSTART | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Increased Diarrhea | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Abdominal Cramping | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Exacerbation of Ulcerative Colitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | COSTART | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Shoulder/Chest Pain | Musculoskeletal and connective tissue disorders | COSTART | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | COSTART | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | COSTART | Systematic Assessment |
| |
| Pain, Abdominal | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Infection | Infections and infestations | COSTART | Systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Rectal Disorder | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Flu Syndrome | Infections and infestations | COSTART | Systematic Assessment |
| |
| Colitis Ulcer | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Fever | General disorders | COSTART | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | COSTART | Systematic Assessment |
| |
| Asthenia | General disorders | COSTART | Systematic Assessment |
| |
| Cough Increased | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | COSTART | Systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | COSTART | Systematic Assessment |
|
Not provided
| 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
| 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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