Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shire
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
