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

Phase 3TerminatedNCT01349673

Bausch Health Americas, Inc.114 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Proctitis Proctosigmoiditis

Interventions

Budesonide FoamDRUG

Topical

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Gastroenterology Consultants, PA

Houston, Texas, United States

Outcomes

Primary Outcomes

Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event

A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Time frame: Baseline through up to Cycle 8 (Cycle=6 weeks)

Secondary Outcomes

Clinically Notable Laboratory Parameters

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.

Time frame: Baseline and Cycle 4 (Cycle=6 weeks)

Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels

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.

Time frame: Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks)

Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline

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.

Time frame: Baseline through up to Cycle 8 (Cycle=6 weeks)

Data from ClinicalTrials.gov

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