Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis

Completed · Phase 4

Conditions studied: Ulcerative Colitis

In brief

This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.

Key facts

Study ID

NCT01124149

Run by

Shire

People needed

759

Starts

2010-06-29

Expected to finish

2012-12-07

Last updated by the study team

2021-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 or older
• Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol
• Diagnosis of active mild to moderate UC (acute flare or newly diagnosed)
• 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.

You may not qualify if…

• Severe UC
• 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.
• Acute flare while on maintenance MMX mesalamine/mesalazine (Lialda, Mezavant, Mezavant XL, Mezavant LP)
• Unsuccessfully treated current acute flare using steroids or 5-ASA doses >3.2 g/day
• Acute flare on a 5-ASA maintenance therapy of >3.2 g/day
• Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening
• History of biologic (anti-TNF agent) use
• 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
• 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

Where it is running

• 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
• Birmingham Gastroenterology Associates, PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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