A clinical trial to study the percentage of subjects in complete (clinical and endoscopic) remission after 12 months of maintenance treatment with 2.4g/day MMXmesalamine/mesalazine given once daily (QD) between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment with 4.8g/day MMX mesalamine /mesalazine given QD.
- Registration Number
- CTRI/2010/091/001221
- Lead Sponsor
- Shire Development Inc.725 Chesterbrook BoulevardWayne, Pennsylvania 19087,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 695
Key Inclusion Criteria:
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 sigmoidoscopy, 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 acute flare through baseline.
5.Satisfactory medical assessment, with the exception of mild to moderate UC, with no clinically significant and relevant abnormalities which would prevent the subject from completing a 14 month study.
6.An understanding, ability, and willingness to fully comply with study procedures and restrictions.
7.Ability to provide personally written, signed, and dated informed consent to participate in the study.
Key Exclusion Criteria:
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.Crohn?s Disease, proctitis (where the extent of inflammation is limited to ≤15 cm from the anus), bleeding disorders, or active peptic ulcer disease.
5.Asthma and known to be 5-ASA sensitive.
6.Positive stool culture for enteric pathogens (including Salmonella, Shigella, Yersinia, Aeromonas, Plesiomonas or Campylobacter). Clostridium difficile toxin present or with ova or parasites as detected by microscopy.
7.Previous colonic surgery.
8.Moderate or severe renal and/or hepatic impairment.
9.Immediate or significant risk of toxic megacolon, in the opinion of the Investigator.
10.History of sensitivity or allergic reaction to salicylates/aspirin.
11.History of an allergic reaction to sulphasalazine, due to the potential risk of cross sensitivity reactions between sulphasalazine and mesalamine /mesalazine.
12.Known or suspected intolerance or hypersensitivity to the IMP, closely related compounds, or any of the stated ingredients.
13.Current use of any medication (including over-the-counter [OTC], herbal or homeopathic preparations) that could affect (improve or worsen) the condition being studied, or could affect the action, absorption, or disposition of the IMP, or clinical or laboratory assessment.
14.Unsuccessfully treated current acute flare using steroids or 5-ASA doses >3.2g/day.
15.Acute flare on a 5-ASA maintenance therapy of >3.2g/day.
16.Systemic or rectal steroid use within the 4 weeks prior to screening or immuno suppressants within the last 6 weeks prior to screening.
17.History of biologic (anti-TNF agent) use.
18.Antibiotic use or repeated use (>3 consecutive days of use at doses above the prescribed OTC dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs (NSAIDs) 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.
19.Oral anticoagulant use (with the exception of subjects who have been on a stable dose of coumarin for at least 90 days prior to the screening visit and who are medically stable).
20.Predisposed to the development of myo- or pericarditis.
21.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.
22.Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the IMP or procedures.
23.History of alcohol or other substance abuse within the last year.
24.Females who are pregnant or lactating, including females with a positive pregnancy test at screening.
25.Previously been entered into this study and subsequently withdrawn.
26.Within 30 days prior to first dose of IMP:
- Used another investigational product
- Been enrolled in a clinical trial (including vaccine trials) that, in the Investigator?s opinion, may impact this Shire-sponsored study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method