Colitis, Ulcerative
Conditions
Keywords
Ulcerative colitis, FE999315, Mesalazine, Colitis, Colitis, Ulcerative
Brief summary
To demonstrate non-inferiority in efficacy of FE 999315 to mesalazine in patients with mild to moderate active ulcerative colitis after 8 weeks of treatment.
Interventions
DRUGBudesonide (6 mg)
Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
DRUGBudesonide (9 mg)
Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
DRUGMesalazine (3,600 mg)
Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients, 16 to 75 years old, diagnosed with ulcerative colitis. * Diagnosis of ulcerative colitis in active phase of mild to moderate entity. * Female patients must fulfill at least one of the following criteria: Post-menopausal (women ≥45 years with no menstrual period for at least 12 months without an alternative medical cause), surgically sterile, using a medically approved contraception throughout the trial period or her male partner using medically approved contraception throughout the trial period. * Male patients must agree to use medically approved contraception throughout the trial period.
Exclusion criteria
* Patients with limited distal proctitis. * Patients with infectious colitis. * Patients with history of colectomy. * Patients with severe diseases in other organs and systems. * Evidence or history of toxic megacolon. * Women who wish to become pregnant during the trial period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score | After 8 weeks | UCDAI is a four-component scale, used to determine the severity of ulcerative colitis. The four components assessed are stool frequency, rectal bleeding, mucosal appearance and physician's rating of disease activity. Score for each component can range between 0-3 and thus, the maximum overall score can be between 0-12. Higher score implies higher disease severity. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving 0 score for subscores of rectal bleeding, stool frequency and mucosal appearance (normal mucosa) in UCDAI after 8 weeks of treatment | 8 weeks |
| Percentage of subjects achieving clinical improvement after 8 weeks of treatment | 8 weeks |
| Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1 | 8 weeks |
| Percentage of subjects achieving symptom resolution after 2 weeks of treatment | 2 weeks |
| Percentage of subjects achieving symptom resolution after 4 weeks of treatment | 4 weeks |
| Percentage of subjects achieving clinical remission after 8 weeks of treatment | 8 weeks |
| Percentage of subjects with endoscopic healing after 8 weeks of treatment | 8 weeks |
| Change from baseline in partial UCDAI score at 2 weeks | 2 weeks |
| Change from baseline in partial UCDAI score at 4 weeks | 4 weeks |
| Change from baseline in partial UCDAI score at 8 weeks | 8 weeks |
| Percentage of subjects achieving symptom resolution after 8 weeks of treatment | 8 weeks |
Countries
Japan
Outcome results
None listed