Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
Launched by SHIRE · May 13, 2010
Trial Information
Current as of July 22, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Adults aged 18 or older
- • 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:
- • 1. Severe UC
- • 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
About Shire
Shire, a global biotechnology company, specializes in developing innovative therapies for rare diseases and complex conditions. With a strong commitment to improving the lives of patients, Shire focuses on areas such as hematology, immunology, neuroscience, and genetic disorders. The company is dedicated to advancing clinical research and delivering breakthrough treatments that address unmet medical needs. Through collaboration and a patient-centric approach, Shire strives to enhance health outcomes and empower individuals affected by challenging health conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Dublin, , Ireland
Bordeaux, , France
Chicago, Illinois, United States
Atlanta, Georgia, United States
Long Beach, California, United States
Anaheim, California, United States
Montreal, Quebec, Canada
Lancaster, Pennsylvania, United States
Great Neck, New York, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Jacksonville, Florida, United States
Hamilton, Ontario, Canada
Madrid, , Spain
Medellin, Antioquia, Colombia
New Smyrna Beach, Florida, United States
Davenport, Iowa, United States
Bonheiden, , Belgium
Roeselare, , Belgium
Port Elizabeth, , South Africa
Troy, Michigan, United States
Headington, Oxfordshire, United Kingdom
Harrow, Middlesex, United Kingdom
San Diego, California, United States
Moline, Illinois, United States
Shreveport, Louisiana, United States
Garden Grove, California, United States
Birmingham, Alabama, United States
Marietta, Georgia, United States
Bucharest, , Romania
Timisoara, , Romania
Cape Town, Western Cape, South Africa
Metairie, Louisiana, United States
Ludhiana, Punjab, India
Dublin, , Ireland
Pune, Maharashtra, India
Monroe, Louisiana, United States
Bristol, Connecticut, United States
Palm Harbor, Florida, United States
Mexico, Missouri, United States
Setauket, New York, United States
Greensboro, North Carolina, United States
Cincinnati, Ohio, United States
Kingsport, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Sandy, Utah, United States
Sandy, Utah, United States
Alexandria, Virginia, United States
Milwaukee, Wisconsin, United States
Kortrijk, , Belgium
Toronto, Ontario, Canada
Quebec City, Quebec, Canada
Quebec, , Canada
Medellin, Antioquia, Colombia
Barranquilla, Atlantico, Colombia
Bogota, Cundinamarca, Colombia
Ceske Budejovice, , Czechia
Ceske Budejovice, , Czechia
Hradec Kralove, , Czechia
Jablonec Nad Nisou, , Czechia
Plzen, , Czechia
Prague 7, , Czechia
Prague, , Czechia
Tabor, , Czechia
Usti Nad Labem, , Czechia
Usti Nad Orlici, , Czechia
Clermont Ferrand, , France
Nantes, , France
Hannover, , Germany
Lueneburg, , Germany
Debrecen, , Hungary
Gyula, , Hungary
Miskolc, , Hungary
Mosonmagyarovar, , Hungary
Vac, , Hungary
Hyderabad, Andhra Pradesh, India
Visakhapatnam, Andhra Pradesh, India
Guwahati, Assam, India
Ahmedabad, Gujarat, India
Mangalore, Kamataka, India
Thiruvananthapuram, Kerala, India
Nagpur, Maharashtra, India
Pune, Maharashtra, India
Jaipur, Rajasthan, India
Jaipur, Rajasthan, India
Lucknow, Up, India
Dublin, , Ireland
Lodz, , Poland
Poznan, , Poland
Sopot, , Poland
Torun, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Targu Mures, Mures, Romania
Bucharest, , Romania
Bucharest, , Romania
Timisoara, , Romania
Bloemfontein, Free State, South Africa
Durban, Kwazulu Natal, South Africa
Durban, Kwazulu Natal, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Patients applied
Trial Officials
Study Director
Study Director
Takeda
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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