Conditions: Proctitis Proctosigmoiditis
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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 281
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Participants who were diagnosed with active mild to moderate UP or UPS, will receive 2 milligrams (mg)/25 milliliter (mL) of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks. arm 2: Participants who were diagnosed with active mild to moderate UP or UPS will receive 25 mL of placebo matching to budesonide foam twice daily for a period of 2 weeks followed by once daily for a period of 4 weeks.

Interventions: intervention 1: Budesonide intervention 2: Placebo
Intervention descriptions: intervention 1: Budesonide will be administered as per the dose and schedule specified in the respective arm. intervention 2: Placebo matching to budesonide will be administered as per the dose and schedule specified in the respective arm.

Protocol document: