Overview

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

Status:
Completed
Trial end date:
2012-12-07
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shire
Treatments:
Mesalamine
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