Summary:
A Phase 3, randomized, double-blind, placebo-controlled, ,ulticenter study to assess the efficacy and safety of one investigational medication for 2 weeks, followed by another investigational medication for 4 weeks, versus Placebo in subjects with active mild to moderate Ulcerative Proctitis or Proctosigmoiditis.
Qualified Participants Must:
Be over 18 years of age
If female and of childbearing(reproductive) potential must have a negative serum pregnancy test at screening and agree to use an acceptable method of contraception throughout their participation in the study
Have a confirmed diagnosis of Active, Mild to Moderate, ulcerative Proctitis or Proctosigmoiditis
Have diagnosis confirmed by Endoscopy
Understand the language of the informed consent form, and be capable and willing to sign the informed consent form