Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)
NCT ID: NCT00446849
Last Updated: 2021-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
290 participants
INTERVENTIONAL
2007-05-01
2009-08-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MMX Mesalamine
MMX Mesalamine
MMX™ mesalamine 2.4g/day to 4.8g/day once-daily (QD) (two to four 1.2g tablets MMX™ mesalamine, dosed QD,respectively).
Interventions
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MMX Mesalamine
MMX™ mesalamine 2.4g/day to 4.8g/day once-daily (QD) (two to four 1.2g tablets MMX™ mesalamine, dosed QD,respectively).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must have a previous diagnosis of UC confirmed by histology and endoscopy or radiology.
3. Males or non-pregnant, non-lactating FOCP who have a negative serum pregnancy test prior to entering the study and who are using adequate forms of contraception for the duration of the study.
4. General medical assessment must be satisfactory and there must not be clinically significant and relevant abnormalities.
5. Subject must have had \>2 acute episodes of UC (a documented episode of increased bowel frequency with rectal blood loss for which UC therapy was intensified) in their medical history.
6. Subjects who have relapsed on maintenance therapy after 2 weeks with doses of mesalamine at: a. \<2.0g/day, will be allowed into the Acute Phase at 2.4g/day QD, or b. between 2.0g/day - 3.0g/day will be allowed into the Acute Phase at 4.8g/day QD.
1. Subjects determined to be quiescent at study entry on prior oral mesalamine therapy will be eligible to enter directly into the Maintenance Phase.
2. UC must have been considered to be quiescent, with scores of zero for both rectal bleeding and bowel movements.
Exclusion Criteria
2. Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening.
3. Subjects must not have used another investigational agent within the last 30 days prior to enrollment.
4. Subjects who have unsuccessfully treated their current relapse with steroids or a mesalamine dose of \>2.0 g/day.
5. Subjects who have relapsed on maintenance therapy with doses of mesalamine \>2.0g/day. If the subject had a recent dose reduction from 2.0g/day to less than or equal to 2.0g/day and relapsed within 2 weeks of that dose reduction, the subject will not be eligible.
6. Subjects who have used systemic or rectal steroids within the last 4 weeks prior to Baseline, immunosuppressants within the last 6 weeks, antibiotic use within the last 7 days or chronic use of any anti-inflammatory drugs within 7 days prior to Baseline.
7. Subjects with hypersensitivity to salicylates/aspirin are excluded.
8. Subjects with moderate or severe hepatic impairment.
9. Subjects with Crohn's Disease, proctitis (where the extent of inflammation is less than or equal to 15cm), short bowel syndrome, bleeding disorders, or active peptic ulcer disease.
10. Subjects with asthma are excluded only if they are known to be mesalamine-sensitive.
11. Subjects with a positive stool culture for enteric pathogens (including Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas or Campylobacter) are excluded, as are those with C. difficile toxin present or with ova or parasites as detected by microscopy.
12. Subjects who have a history of previous colonic surgery.
13. Subjects with moderate or severe renal impairment are contra-indicated for treatment with mesalamine compounds and are excluded from the study.
14. Subjects with current or recurrent disease that could affect the colon, the action, absorption or disposition of the study drug, or clinical or laboratory assessments.
15. Subjects with current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the study drug or procedures.
16. Subjects with a history of alcohol or other substance abuse within the previous year.
17. Subjects who withdrew from a mesalamine trial due to a possibly or probably related severe AE or SAE are not eligible to enter this study.
1. Subjects who have withdrawn from the Acute Phase before study visit A3.
2. Subjects with severe UC according to the PGA.
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham Gastroenterology Assoc.
Birmingham, Alabama, United States
Clopton Clinic
Jonesboro, Arkansas, United States
VA Medical Center - Long Beach
Long Beach, California, United States
Sharp Rees-Stealy Medical Group
San Diego, California, United States
Clinical Applications Laboratories, Inc.
San Diego, California, United States
South Denver Gastroenterology, P.C.
Englewood, Colorado, United States
The Center for GI Medicine of Fairfield & Westchester, P.C.
Greenwich, Connecticut, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
Connecticut Gastroenterology Associates
New Haven, Connecticut, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Advanced Digestive Care, PA
Clearwater, Florida, United States
Southern Clinical Research Consultants
Hollywood, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
United Medical Research
New Smyrna Beach, Florida, United States
Advanced Gastroenterology Associates
Palm Harbor, Florida, United States
Soapstone Ctr. for Clin. Rsrch
Decatur, Georgia, United States
Gastroenterology Assoc./Cen.GA
Macon, Georgia, United States
NW GA Gastroenterology
Marietta, Georgia, United States
Midwest Clinical Research Associates
Moline, Illinois, United States
Accelovance
Peoria, Illinois, United States
Rockford Gastroenterology Associates
Rockford, Illinois, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Gastrointestinal Clinic of Quad Cities
Davenport, Iowa, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
GI Associates
Overland Park, Kansas, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Digestive Disorders Associates Research Division
Annapolis, Maryland, United States
Maryland Clinical Trials
Annapolis, Maryland, United States
Maryland Digestive Disease Research, LLC
Laurel, Maryland, United States
Center for Digestive Health
Troy, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Center for Digestive and Liver Diseases
Mexico, Missouri, United States
Clinical Research Group of Montana, PLLC
Bozeman, Montana, United States
Marlboro Gastroenterology
Manalapan, New Jersey, United States
Western Suffolk Gastroenterology Associates, LLP
Bay Shore, New York, United States
Long Island Clinical Research Associates, LLP
Long Island City, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Digestive Medicine of Long Island
New Hyde Park, New York, United States
Mount Sinai and Metropolitan Hospital
New York, New York, United States
Upstate Gastroentrology Associates
Troy, New York, United States
Peters Medical Research
High Point, North Carolina, United States
East Carolina Gastroenterology
Jacksonville, North Carolina, United States
Gastroenterology Associates
Beachwood, Ohio, United States
Consultants for Clinical Research, Inc.
Cincinnati, Ohio, United States
Digestive Health Network
Cincinnati, Ohio, United States
Gastro Consultants of Greater Cincinnati
Cincinnati, Ohio, United States
Gild Consultants, P.C.
Dayton, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Guthrie Clinic
Sayre, Pennsylvania, United States
ClinSearch
Chattanooga, Tennessee, United States
Gastroenterology of Midsouth
Germantown, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Houston Endoscopy & Research Center
Houston, Texas, United States
Gastroenterology Clinic of San Antonio
San Antonio, Texas, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
New River Valley Research
Christiansburg, Virginia, United States
Inland Empire Gastroenterology, P.S.
Spokane, Washington, United States
Spokane Digestive Disease Center, P.S.
Spokane, Washington, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Aurora Health Center- Waukesha
Waukesha, Wisconsin, United States
Countries
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References
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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.
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.
Related Links
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FDA recall information
FDA-approved label
Other Identifiers
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SPD476-404
Identifier Type: -
Identifier Source: org_study_id
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