A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA
- Conditions
- K51-K51
- Registration Number
- PER-112-07
- Lead Sponsor
- Shire Pharmaceutical Development Ltd.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 0
• Adult subjects (> 18 years old) of both sexes. The participants must be postmenopausal women, surgically or biologically sterilized or have negative results in a urine pregnancy test in the selection and use an adequate contraceptive.
• Subjects with a previous diagnosis of UC confirmed by histology, who are considered to be in remission <30 days with a score <1 on endoscopy and a combined symptom score (rectorrhagia and frequency of bowel movements) <1.
• Subjects receiving a stable dose of 5-aminosalicylic acid (5-ASA) at2.4g / day for at least 30 days prior to the baseline visit, who have had> 1 acute episode of UC (documented episode of increased frequency) of stools with rectal bleeding that forced to intensify the treatment of UC) in the last 12 months and> 2 acute episodes in his medical history
• Subjects with proctitis only in the most recent recurrence (degree of inflammation <15 cm from the year), previous surgery for colon resection or Crohn´s disease.
• The use of systemic or rectal asteroids in the 30 days prior to the baseline visit, of immunosuppressants in the previous 6 weeks, of antibiotics in the previous 2 weeks, of treatment with anti-TNF antibodies in the previous 12 weeks, the repeated use of Anti-inflammatory drugs in the previous 7 days or the use of rectal 5-ASA before the baseline visit will exclude the subjects from the study.
• Subjects with hypersensitivity to salicylates and subjects with asthma sensitive to 5-ASA.
• Subjects with moderate / severe renal impairment (defined by a creatinine level> 2 mg / dL) have treatment contraindicated with 5-ASA compounds and will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Defined by a score <1 on endoscopy. The main analysis will compare the main efficacy variable between SPD476 and Asacol® in the population per protocol (PP).<br>Measure:Percentage of subjects in endoscopic remission at month 6 in each treatment group<br>Timepoints:month 6<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The time to endoscopic recurrence will be presented and compared using the Kaplan-Meier methodology.<br>Measure:Time to endoscopic recurrence<br>Timepoints:until endoscopic recurrence<br>;<br>Outcome name:The score in the IDA-ECU and its components will be duly summarized at each relevant time point and by change with respect to the baseline value; it will be further compared between the treatment groups.<br>Measure:Score in the IDA-ECU<br>Timepoints:6 months<br>;<br>Outcome name:The total score in the CASEII and its components will be duly summarized at each relevant time point and by change with respect to the base value; it will be further compared between the treatment groups.<br>Measure:Quality of life<br>Timepoints:6 months<br>