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To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMX Mesalamine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMX Mesalamine | Drug | MMXâ„¢ mesalamine 2.4g/day to 4.8g/day once-daily (QD) (two to four 1.2g tablets MMXâ„¢ mesalamine, dosed QD,respectively). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Recurrence of Ulcerative Colitis (UC) During the Maintenance Phase at 6 Months | Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Recurrence of UC During the Maintenance Phase at 12 Months | Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. | 12 Months |
| Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 6 Months |
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Inclusion Criteria - Acute Phase:
Inclusion Criteria - Maintenance Phase:
Exclusion Criteria - Acute Phase:
Exclusion Criteria - Maintenance Phase (in addition to above inclusion for the Acute Phase):
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Gastroenterology Assoc. | Birmingham | Alabama | 35209 | United States | ||
| Clopton Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21837775 | Result | Kane S, Katz S, Jamal MM, Safdi M, Dolin B, Solomon D, Palmen M, Barrett K. Strategies in maintenance for patients receiving long-term therapy (SIMPLE): a study of MMX mesalamine for the long-term maintenance of quiescent ulcerative colitis. Inflamm Bowel Dis. 2012 Jun;18(6):1026-33. doi: 10.1002/ibd.21841. Epub 2011 Aug 11. | |
| 25193617 |
| Label | URL |
|---|---|
| FDA recall information | View source |
Not provided
A total of 290 subjects were enrolled in the study (138 in the acute phase and 152 that went directly into the maintenance phase). The 56 subjects that completed the acute phase entered the maintenance phase making a total of 208 subjects in the maintenance phase of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multi-Matrix System (MMX) Mesalamine | Subjects whose ulcerative colitis (UC) was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed orally once-daily [QD] at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Acute Phase |
|
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Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: [(Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals)] x 100. |
| 6 Months |
| Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 12 Months | Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: (Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals) x 100. | 12 months |
| Quiescent UC During the Maintenance Phase at 12 Months | Quiescent UC is defined as scores of 0 for both rectal bleeding and bowel movements. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Bowel movements are assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day). | 12 Months |
| Endoscopic Remission of UC During the Maintenance Phase at 12 Months | Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding]. | 12 Months |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| VA Medical Center - Long Beach | Long Beach | California | 90822 | United States |
| Sharp Rees-Stealy Medical Group | San Diego | California | 92101 | United States |
| Clinical Applications Laboratories, Inc. | San Diego | California | 92103 | United States |
| South Denver Gastroenterology, P.C. | Englewood | Colorado | 80113 | United States |
| The Center for GI Medicine of Fairfield & Westchester, P.C. | Greenwich | Connecticut | 06830 | United States |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | United States |
| Connecticut Gastroenterology Associates | New Haven | Connecticut | 06510 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States |
| Advanced Digestive Care, PA | Clearwater | Florida | 33756 | United States |
| Southern Clinical Research Consultants | Hollywood | Florida | 33021 | United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | United States |
| United Medical Research | New Smyrna Beach | Florida | 32168 | United States |
| Advanced Gastroenterology Associates | Palm Harbor | Florida | 34684 | United States |
| Soapstone Ctr. for Clin. Rsrch | Decatur | Georgia | 30034 | United States |
| Gastroenterology Assoc./Cen.GA | Macon | Georgia | 31201 | United States |
| NW GA Gastroenterology | Marietta | Georgia | 30060 | United States |
| Midwest Clinical Research Associates | Moline | Illinois | 61265 | United States |
| Accelovance | Peoria | Illinois | 61602 | United States |
| Rockford Gastroenterology Associates | Rockford | Illinois | 61107 | United States |
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| Gastrointestinal Clinic of Quad Cities | Davenport | Iowa | 52807 | United States |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | United States |
| GI Associates | Overland Park | Kansas | 66212 | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71103 | United States |
| Digestive Disorders Associates Research Division | Annapolis | Maryland | 21401 | United States |
| Maryland Clinical Trials | Annapolis | Maryland | 21401 | United States |
| Maryland Digestive Disease Research, LLC | Laurel | Maryland | 20707 | United States |
| Center for Digestive Health | Troy | Michigan | 48098 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Center for Digestive and Liver Diseases | Mexico | Missouri | 65265 | United States |
| Clinical Research Group of Montana, PLLC | Bozeman | Montana | 59718 | United States |
| Marlboro Gastroenterology | Manalapan | New Jersey | 07726 | United States |
| Western Suffolk Gastroenterology Associates, LLP | Bay Shore | New York | 11706 | United States |
| Long Island Clinical Research Associates, LLP | Long Island City | New York | 11021 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Digestive Medicine of Long Island | New Hyde Park | New York | 11042 | United States |
| Mount Sinai and Metropolitan Hospital | New York | New York | 10128 | United States |
| Upstate Gastroentrology Associates | Troy | New York | 12180 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| East Carolina Gastroenterology | Jacksonville | North Carolina | 28546 | United States |
| Gastroenterology Associates | Beachwood | Ohio | 44122 | United States |
| Consultants for Clinical Research, Inc. | Cincinnati | Ohio | 45219 | United States |
| Digestive Health Network | Cincinnati | Ohio | 45220 | United States |
| Gastro Consultants of Greater Cincinnati | Cincinnati | Ohio | 45242 | United States |
| Gild Consultants, P.C. | Dayton | Ohio | 45415 | United States |
| Central Sooner Research | Norman | Oklahoma | 73069 | United States |
| Guthrie Clinic | Sayre | Pennsylvania | 18840 | United States |
| ClinSearch | Chattanooga | Tennessee | 37404 | United States |
| Gastroenterology of Midsouth | Germantown | Tennessee | 38138 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Houston Endoscopy & Research Center | Houston | Texas | 77024 | United States |
| Gastroenterology Clinic of San Antonio | San Antonio | Texas | 78229 | United States |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | United States |
| New River Valley Research | Christiansburg | Virginia | 24073 | United States |
| Inland Empire Gastroenterology, P.S. | Spokane | Washington | 99204 | United States |
| Spokane Digestive Disease Center, P.S. | Spokane | Washington | 99204 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
| Aurora Sinai Medical Center | Milwaukee | Wisconsin | 53233 | United States |
| Aurora Health Center- Waukesha | Waukesha | Wisconsin | 53186 | United States |
| Yarlas A, Yen L, Hodgkins P. The relationship among multiple patient-reported outcomes measures for patients with ulcerative colitis receiving treatment with MMX (R) formulated delayed-release mesalamine. Qual Life Res. 2015 Mar;24(3):671-83. doi: 10.1007/s11136-014-0797-2. Epub 2014 Sep 6. |
| FDA-approved label | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MMX Mesalamine (Maintenance Phase) | Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase. A total of 208 subjects entered the maintenance phase (152 whose UC was quiescent at screening + 56 whose UC was quiescent after the acute phase). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Clinical Recurrence of Ulcerative Colitis (UC) During the Maintenance Phase at 6 Months | Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. | Maintenance phase efficacy population (MPEP) includes all subjects who, during the maintenance phase, took at least 1 dose of study medication and had at least 1 post-dose efficacy assessment. | Posted | Number | participants | 6 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Recurrence of UC During the Maintenance Phase at 12 Months | Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. | MPEP | Posted | Number | participants | 12 Months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 6 Months | Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: [(Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals)] x 100. | MPEP with non-missing data for clinical recurrence at 6 months. | Posted | Number | Percent of participants | 6 Months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 12 Months | Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding. Compliance is a subject's adherence to a recommended course of treatment and for this study is calculated: (Sum of days' supplies dispensed) divided by (Sum of days in all refill intervals) x 100. | MPEP with non-missing data for clinical recurrence at 12 months. | Posted | Number | Percent of participants | 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Quiescent UC During the Maintenance Phase at 12 Months | Quiescent UC is defined as scores of 0 for both rectal bleeding and bowel movements. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Bowel movements are assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day). | MPEP with non-missing data at 12 months. | Posted | Number | Participants | 12 Months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Endoscopic Remission of UC During the Maintenance Phase at 12 Months | Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal [intact vascular pattern; no friability or granulation], 1 = mild [erythema; decreased vascular pattern; minimal granularity], 2 = moderate [marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations], 3 = severe [ulceration; spontaneous bleeding]. | MPEP with non-missing data at 12 months. | Posted | Number | Participants | 12 Months |
|
|
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Safety population defined as all subjects who took at least one dose of study medication. In the acute phase 138 were randomized, but only 137 received at least one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MMX Mesalamine (Acute Phase) | Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day). | 3 | 137 | 0 | 137 | ||
| EG001 | MMX Mesalamine (Maintenance Phase) | Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase. | 9 | 208 | 12 | 208 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrilation | Cardiac disorders |
| |||
| Stent occlusion | Injury, poisoning and procedural complications |
| |||
| Headache | Nervous system disorders |
| |||
| Angina unstable | Cardiac disorders |
| |||
| Hematochezia | Gastrointestinal disorders |
| |||
| Ileus | Gastrointestinal disorders |
| |||
| Pancreatitis | Gastrointestinal disorders |
| |||
| Cholecystitis acute | Hepatobiliary disorders |
| |||
| Cellulitis | Infections and infestations |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Schizophrenia | Psychiatric disorders |
| |||
| Endometriosis | Reproductive system and breast disorders |
| |||
| Hypertension | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D010349 | Patient Compliance |
| C537984 | Charcot-Marie-Tooth disease, Type 1C |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
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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 |
Not provided
Not provided
| Consent withdrawn |
|
| Lost to Follow-up |
|
| Pregnancy |
|
| noncompliance |
|
| prohibited medication use |
|
| antibiotic use |
|
| study closure |
|
| hydrocodone use |
|
| concomitant medication use |
|
| Title | Measurements |
|---|
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