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

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).

Full Title of Study: “A Phase 3, Open Label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2014

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.

Interventions

  • Drug: Budesonide Foam
    • Topical

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event
    • Time Frame: 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 Measures

  • Clinically Notable Laboratory Parameters
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bausch Health Americas, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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