None listed
Conditions
Interventions
Group 1 Type of group
SPD476 2.4 g / day administered 1 v / d for 6 months
Group name:Group 2 Type of group
Asacol® 1.6 g / day administered 2 v / d for 6 months
Sponsors
Shire Pharmaceutical Development Ltd.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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 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
Exclusion criteria
Exclusion criteria: • Subjects with proctitis only in the most recent recurrence (degree of inflammation 2 mg / dL) have treatment contraindicated with 5-ASA compounds and will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). Measure:Percentage of subjects in endoscopic remission at month 6 in each treatment group Timepoints:month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The time to endoscopic recurrence will be presented and compared using the Kaplan-Meier methodology. Measure:Time to endoscopic recurrence Timepoints:until endoscopic recurrence ; 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. Measure:Score in the IDA-ECU Timepoints:6 months ; 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. Measure:Quality of life Timepoints:6 months | — |
Contacts
Public ContactLourdes Teresa Paz
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed