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

NCT03412682 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2020-06-18

No results posted yet for this study

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.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Budesonide (6 mg)

Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.

DRUG

Budesonide (9 mg)

Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.

DRUG

Mesalazine (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 & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-02
Primary Completion
2020-05-11
Completion
2020-05-26

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03412682 on ClinicalTrials.gov