Conditions: Proctitis Proctosigmoiditis
Keywords: Open-label 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: NA | Intervention model: SINGLE_GROUP
Enrollment: 114
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).

Detailed description:
This is a Phase 3, multicenter, open-label study in participants who previously participated in a Salix-sponsored budesonide rectal foam study for the treatment of UP or UPS. Approximately 300 participants were to be enrolled into the study and receive budesonide foam cyclically for 6 weeks (twice a day \[BID\] for 2 weeks and once daily \[QD\] for 4 weeks). The study was to continue until regulatory approval of budesonide foam occurred or the sponsor decided to terminate the study.

Arms:
arm 1: Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle.

Interventions: intervention 1: Budesonide Foam
Intervention descriptions: intervention 1: Topical

Protocol document: