Status:
COMPLETED
To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
16-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2020
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT03412682
Start Date
March 2 2018
End Date
May 26 2020
Last Update
June 18 2020
Active Locations (72)
Enter a location and click search to find clinical trials sorted by distance.
1
Ferring Investigator Site JPN27
Nagoya, Aichi-ken, Japan
2
Ferring Investigator Site JPN52
Toyoake-shi, Aichi-ken, Japan
3
Ferring Investigator Site JPN47
Toyota-shi, Aichi-ken, Japan
4
Ferring Investigator Site JPN69
Abiko-shi, Chiba, Japan