Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

Exclusion Criteria

• •History or current diagnosis of Crohn's disease and indeterminate colitis.
• •Prior gastrointestinal surgery except appendectomy and hernia.
• •Concomitant active gastrointestinal disease or distortion of intestinal anatomy.
• •History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
• •Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
• •Uncontrolled abnormal thyroid function.
• •Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
• •Hemoglobin levels less than (\<) 7.5 grams /deciliter (g/dL).
• •History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
• •Renal disease manifested by greater than (\>) 2.0 milligrams/deciliter (mg/dL) serum creatinine.
• •History of avascular hip necrosis, active tuberculosis, ocular herpes simplex or ocular varicella zoster, malignant disease, and human immunodeficiency virus (HIV) or hepatitis B or C.
• •Adrenal insufficiency.
• •Active systemic or cutaneous infection or toxic megacolon, fistula, perforation or abscess.
• •History of uncontrolled psychiatric disorders or seizure disorders.
• •History of asthma requiring ongoing use of inhaled steroids.
• •Recent history of drug or alcohol abuse.
• •Positive stool test for bacterial pathogens, Clostridium difficile toxin, or ovum and parasites.
• •Vaccination within 28 days prior to randomization.
• •Allergies to budesonide or to any other items used in its preparation.
• •Participation in another clinical trial in the past 30 days.
• •Pregnant or at risk of pregnancy.
• •Taking a prohibited medication. Some medications to treat UP/UPS are prohibited during participation in the study, including laxatives and anti-diarrhea medications; however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant medicines) are also prohibited.