To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis

Browse trials for

• Colitis 1,074
• Colitis, Ulcerative 1,485
• Ulcer 2,023

Keywords

• Ulcerative colitis
• FE999315
• Mesalazine
• Colitis
• Colitis, Ulcerative

Study arms

• Experimental
  Budesonide (6 mg)

  Drug: Budesonide (6 mg)

• Experimental
  Budesonide (9 mg)

  Drug: Budesonide (9 mg)

• Active comparator
  Mesalazine (3,600 mg)

  Drug: Mesalazine (3,600 mg)

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.

  Also known as: FE 999315

• 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.

  Also known as: FE 999315

• 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.

Primary outcomes

1. Change from baseline of total Ulcerative Colitis Disease Activity Index (UCDAI) scores after 8 weeks of treatment using the mucosal appearance score

   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.

   Time frame: After 8 weeks

Secondary outcomes

1. Percentage of subjects achieving clinical remission after 8 weeks of treatment

   Time frame: 8 weeks

2. 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

   Time frame: 8 weeks

3. Percentage of subjects achieving clinical improvement after 8 weeks of treatment

   Time frame: 8 weeks

4. Percentage of subjects achieving endoscopic improvement after 8 weeks of treatment for subjects with baseline UCDAI mucosal appearance subscore greater than equal to [≥]1

   Time frame: 8 weeks

5. Percentage of subjects achieving symptom resolution after 2 weeks of treatment

   Time frame: 2 weeks

6. Percentage of subjects achieving symptom resolution after 4 weeks of treatment

   Time frame: 4 weeks

7. Percentage of subjects achieving symptom resolution after 8 weeks of treatment

   Time frame: 8 weeks

8. Percentage of subjects with endoscopic healing after 8 weeks of treatment

   Time frame: 8 weeks

9. Change from baseline in partial UCDAI score at 2 weeks

   Time frame: 2 weeks

10. Change from baseline in partial UCDAI score at 4 weeks

    Time frame: 4 weeks

11. Change from baseline in partial UCDAI score at 8 weeks

    Time frame: 8 weeks