The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis

Phase 3

Terminated

Conditions: Proctitis
Proctosigmoiditis

Interventions: Drug: Budesonide Foam

Registration Number: NCT01349673

Lead Sponsor: Bausch Health Americas, Inc.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 114

Inclusion Criteria

Male or non-pregnant, non-breast-feeding females ≥18 years old.
Participant was previously diagnosed with active mild to moderate UP/UPS and was currently experiencing symptoms of active UP/UPS disease after having completed participation in Salix's BUCF3001 (NCT01008410) or BUCF3002 (NCT01008423) study.
Willingness to undergo sigmoidoscopy.

Exclusion Criteria

Active systemic, ocular, or cutaneous infection (for example, parasitic, fungal, amoebic, viral, or bacterial disease).
History of sclerosing cholangitis, cirrhosis, or hepatic impairment, including chronic hepatitis of any etiology.
Participant took systemic, inhaled, oral, topical, or rectal corticosteroids (other than budesonide rectal foam) within 7 days of starting a treatment cycle.
Participant took ketoconazole and other potent CYP3A4 inhibitors within 7 days of starting a treatment cycle.
Participant took diuretics with cardiac glycosides.
Unstable significant cardiovascular, hepatic, renal, endocrine, neurologic, or pulmonary disease.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Budesonide Foam	Budesonide Foam	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.

Primary Outcome Measures

Name	Time	Method
Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event	Baseline through up to Cycle 8 (Cycle=6 weeks)	A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Secondary Outcome Measures

Name	Time	Method
Clinically Notable Laboratory Parameters	Baseline and Cycle 4 (Cycle=6 weeks)	Clinically notable laboratory parameters are defined as clinical laboratory values outside the reference range. Reference ranges for the clinical notable laboratory parameters: Aspartate Aminotransferase - 0-37 microliters (U/L); Alanine Aminotransferase - 0-47 U/L; Lactate Dehydrogenase - 110-250 U/L. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels	Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks)	Fasting cortisol levels were evaluated, and cortisol was taken in the morning (AM cortisol) approximately 2 to 4 hours after waking. Data for cycles with more than 15 participants at the Cycle Baseline is reported.
Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline	Baseline through up to Cycle 8 (Cycle=6 weeks)	A full or complete physical examination was performed at the Study Baseline. This physical examination included (but was not limited to): general appearance, head, ear, eyes, nose, throat, respiratory, cardiovascular, gastrointestinal, abdominal, neurological, lymphatic, dermatologic, and musculoskeletal. A symptom-directed physical examination was performed on Visit 2 (Day 1) to Visit 4 (Day 42) per Cycle (at the Investigator's discretion) and as needed for unscheduled clinic visits. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.