A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 12.1Level: LLTClassification code 10045365Term: Ulcerative colitis

• Registration Number: EUCTR2009-017044-13-FR
• Lead Sponsor: Shire Development Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-22
• Study Completion: 2012-12-14
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Subjects meeting all of the criteria listed below at screening may be included in the study:

1. Adults aged 18 years 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 with a total score of 4–10 inclusive on the modified UC-DAI with an endoscopy score of =1 and a PGA of =2)*. The original diagnosis of UC must be established by endoscopy, colonoscopy, or barium enema and have compatible histology.

4. Stable maintenance therapy of 5-ASA =3.2g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare. Stable maintenance therapy is defined as no change in dose, or no initiation of 5-ASA, from the onset of the acute flare through baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are excluded from the study if any of the following criteria are met at screening:

1. Severe UC (assessed by PGA =3).*

2. Acute flare with onset >6 weeks prior to baseline.

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 >3.2g/day.

5. Acute flare on a 5-ASA maintenance therapy of >3.2g/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 investigational medicinal product, or clinical or laboratory assessments.

* The symptom parameters of the modified UC-DAI (rectal bleeding and stool frequency) will be assessed at screening and baseline, and endoscopy and PGA scores will be obtained at baseline to confirm eligibility.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified