Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
NCT ID: NCT01124149
Last Updated: 2021-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
759 participants
INTERVENTIONAL
2010-06-29
2012-12-07
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/ mesalazine
MMX mesalamine/ mesalazine
4.8g/day given QD (four 1.2g tablets) for 8 weeks, 2.4g/day given QD (two 1.2g tablets) for 12 months
Interventions
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MMX mesalamine/ mesalazine
4.8g/day given QD (four 1.2g tablets) for 8 weeks, 2.4g/day given QD (two 1.2g tablets) for 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol
3. Diagnosis of active mild to moderate UC (acute flare or newly diagnosed)
4. Stable maintenance therapy of 5-ASA less than or equal to 3.2 g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare.
Exclusion Criteria
2. Acute flare with onset greater than \>6 weeks prior to baseline while on maintenance therapy. There is no limit to the onset of flare prior to baseline if the flare is untreated.
3. Acute flare while on maintenance MMX mesalamine/mesalazine (Lialda, Mezavant, Mezavant XL, Mezavant LP)
4. Unsuccessfully treated current acute flare using steroids or 5-ASA doses \>3.2 g/day
5. Acute flare on a 5-ASA maintenance therapy of \>3.2 g/day
6. Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening
7. History of biologic (anti-TNF agent) use
8. Antibiotic use or repeated use (\>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to screening. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted
9. Current or recurrent disease, other than UC, that could affect the colon, the action, absorption, or disposition of the IMP, or clinical or laboratory assessments
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 Associates, PC
Birmingham, Alabama, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Digestive & Liver Disease Specialists
Garden Grove, California, United States
Long Beach VA Medical Center
Long Beach, California, United States
Clinical Applications Laboratories, Inc.
San Diego, California, United States
Conneticut Gastroenterolgy Institute
Bristol, Connecticut, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
United Medical Research
New Smyrna Beach, Florida, United States
Advances Gastroenterology Associates
Palm Harbor, Florida, United States
Atlanta Gastroenterology Associates, LLC
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates
Marietta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Midwest Clinical Research Associates
Moline, Illinois, United States
Gastrointestinal Clinic of Quad Cities
Davenport, Iowa, United States
New Orleans Research Institute
Metairie, Louisiana, United States
Delta Research Partners
Monroe, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Digestive Disorders Associates
Annapolis, Maryland, United States
Digestive Disease Associates
Baltimore, Maryland, United States
Center for Digestive Health
Troy, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Center for Digestive & Liver Disease, Inc.
Mexico, Missouri, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States
Gastrointestinal Research Associates
Setauket, New York, United States
LeBauer Research Associates
Greensboro, North Carolina, United States
Ohio Gastroenterolgy and Liver Intstitute
Cincinnati, Ohio, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States
Gastroenterology Associates, LLC
Kingsport, Tennessee, United States
S.D. Khan
Houston, Texas, United States
Gastroenterology Clinic of San Antonio, PA
San Antonio, Texas, United States
Colon and Rectal Disease Center
Sandy City, Utah, United States
Physicians Research Option, LLC
Sandy City, Utah, United States
Alexandria Clinical Research
Alexandria, Virginia, United States
Wisconsin Center for Advances Research
Milwaukee, Wisconsin, United States
Imelda General Hospital
Bonheiden, , Belgium
vzw AZ Groeninge
Kortrijk, , Belgium
Heilig Hart ziekenhuis vzw Roeselare-Menen
Roeselare, , Belgium
McMaster University Medical Centre
Hamilton, Ontario, Canada
Toronto Digestive Disease Associates, Inc.
Toronto, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
CHAUQ- Hopital du Saint-Sacrement
Québec, Quebec, Canada
Alpha Recherche Clinique
Québec, Quebec, Canada
Hospital pablo Tobon uribe
Medellín, Antioquia, Colombia
Promotora medica las Americas S.A.
Medellín, Antioquia, Colombia
Ugasend S.A.
Barranquilla, Atlántico, Colombia
FOQUS, Centro de Investigacion Clinica
Bogota, Cundinamarca, Colombia
Private Gastroenterology centre
České Budějovice, , Czechia
Derma Plus s.r.o. Gastroenterology
České Budějovice, , Czechia
Hepato-Gastroenterology HK s.r.o.
Hradec Králové, , Czechia
Nemocnice Jablonec nad Nisou
Jablonec nad Nisou, , Czechia
Faculty hospital Plzen- Lochotin
Pilsen, , Czechia
IKEM (Institute klinicke a experimentalni mediciny)
Prague, , Czechia
Klinicke Centrum ISCARE I.V.F.
Prague, , Czechia
Nemocnice Tabor a.s.
Tábor, , Czechia
Massarykova Nemocnice-Masaryk Hospital
Ústí nad Labem, , Czechia
Orlickoustecka nemocnice a.s. (Hospital)
Ústí nad Orlicí, , Czechia
Hopital Saint Andre
Bordeaux, , France
CHU Estaing
Clermont-Ferrand, , France
CHU Nantes- Hotel Dieu
Nantes, , France
Medizinische Hochschule Hannover/ Zentrum Innere Medizin/Gastroenterologie
Hanover, , Germany
Stawdtisches Klinikum Lueneburg Gastroenterologie
Lüneburg, , Germany
Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum III. sz. Belgyogyazati Klinika
Debrecen, , Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium
Gyula, , Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyrtrmi Oktato Korhaz, II. Belgyogyaszat
Miskolc, , Hungary
Karolina Korhaz, Belgyogyaszat es Gasztroenterologia
Mosonmagyaróvár, , Hungary
Javorszky Odon Varosi Korhaz, Gasztroenterologia
Vác, , Hungary
Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, India
Manikya Institute of Gastroenterology & Hepatology
Visakhapatnam, Andhra Pradesh, India
Institute of Digestive & Liver Diseases
Guwahati, Assam, India
Mehta Hospital
Ahmedabad, Gujarat, India
Kasturba Medical College Hospital
Mangalore, Kamataka, India
Sree Gokulam Medical College and Research Foundation
Thiruvananthapuram, Kerala, India
Gastroenterology & Endoscopy Centre
Nagpur, Maharashtra, India
Sahyandri Speciality Hospital
Pune, Maharashtra, India
Poona Hospital & Research Centre
Pune, Maharashtra, India
Dayanand Medical College and hospital
Ludhiana, Punjab, India
S R Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
Dr. Nijhawan Clinic
Jaipur, Rajasthan, India
Chhatrapati Shahuji Maharaj Medical University
Lucknow, Uttar Pradesh, India
Adelaide and Meath Hospital
Dublin, , Ireland
St Vincents' University Hospital
Dublin, , Ireland
Beaumont Hospital
Dublin, , Ireland
NZOZ Centrum Medyczne Szpital Sw. Rodziny
Lodz, , Poland
NZOZ Centrum Medyczne HCP
Poznan, , Poland
Endoskopia Sp z o.o.
Sopot, , Poland
Indyw. Spec. Prakt. Lek. w Dziedzinie Chirurgii Ogolnej i Gastroenterologii
Torun, , Poland
Nzoz Vivamed
Warsaw, , Poland
LexMedica
Wroclaw, , Poland
EMC Instytut Medyczny SA
Wroclaw, , Poland
CMI de Gastroenterologie
Târgu Mureş, Mureș County, Romania
Clinical Hospital "Dr. I. Cantacuzino"
Bucharest, , Romania
Institutul Clinic Fundeni
Bucharest, , Romania
Emergency University Clinical Hospital Bucuresti
Bucharest, , Romania
Policlinic Algomed SRL
Timișoara, , Romania
Policlinica "Dr. Citu" SRL
Timișoara, , Romania
Rose Park Hospital Boanerges CC Trials
Bloemfontein, Free State, South Africa
St. Augustine's Hospital
Durban, KwaZulu-Natal, South Africa
Parklands Medical Centre
Durban, KwaZulu-Natal, South Africa
Panorama Medi-Clinic
Cape Town, Western Cape, South Africa
Louis Leipoldt Medical Centre
Cape Town, Western Cape, South Africa
Kingsbury Hospital
Cape Town, Western Cape, South Africa
Greenacres Hospital
Port Elizabeth, , South Africa
Hospital Universitario La Princesa
Madrid, , Spain
St Mark's Hospital
Harrow, Middlesex, United Kingdom
John Radcliffe Hospital
Headington, Oxfordshire, United Kingdom
Countries
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References
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Stevens TW, Gecse K, Turner JR, de Hertogh G, Rubin DT, D'Haens GR. Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2333-2342. doi: 10.1016/j.cgh.2020.08.019. Epub 2020 Aug 13.
Willian MK, D'Haens G, Yarlas A, Joshi AV. Changes in health-related quality of life and work-related outcomes for patients with mild-to-moderate ulcerative colitis receiving short-term and long-term treatment with multimatrix mesalamine: a prospective, open-label study. J Patient Rep Outcomes. 2018 Apr 27;2:22. doi: 10.1186/s41687-018-0046-5. eCollection 2018 Dec.
Yarlas A, D'Haens G, Willian MK, Teynor M. Health-Related Quality of Life and Work-Related Outcomes for Patients With Mild-to-Moderate Ulcerative Colitis and Remission Status Following Short-Term and Long-Term Treatment With Multimatrix Mesalamine: A Prospective, Open-Label Study. Inflamm Bowel Dis. 2018 Jan 18;24(2):450-463. doi: 10.1093/ibd/izx041.
Other Identifiers
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2009-017044-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD476-409
Identifier Type: -
Identifier Source: org_study_id
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