Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
Condition: Proctitis; Proctosigmoiditis
MeSH terms: Proctitis; Proctocolitis; Ulcer
Intervention: Budesonide; Placebo
Intervention description: Budesonide will be administered as per the dose and schedule specified in the respective arm.; Placebo matching to budesonide will be administered as per the schedule specified in the respective arm.
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 265.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Proctitis; Proctosigmoiditis; Ulcerative; Salix; Budesonide foam; Budesonide; Rectal; Gastrointestinal; Colitis; UC; UP; UPS; Additional relevant MeSH terms:; Proctocolitis; Ulcer; Colitis, Ulcerative; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Intestinal Diseases; Colonic Diseases; Sigmoid Diseases; Pathologic Processes; Inflammatory Bowel Diseases; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Anti-Asthmatic Agents; Respiratory System Agents; Therapeutic Uses; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Inflammatory Agents

Summary:

      The purpose of this study is to establish the efficacy profile of rectally administered
      budesonide foam, as compared to an equivalent volume of rectally administered placebo foam
      over the same dosing schedule, in participants who present with a diagnosis of active, mild
      to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the
      study, eligible participants will be allowed to maintain previously established oral
      5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily sign written informed consent.

          -  Male or non-pregnant and non-lactating females.

          -  Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate UP or UPS,
             with disease extending at least 5 centimeters (cm) but no further than 40 cm from the
             anal verge.

          -  Must possess a baseline Modified Mayo Disease Activity Index (MMDAI) score between 5
             and 10.

        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.