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

Proctitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01349673
• Other study ID #: BFPS3073
• Status: Terminated
• Phase: Phase 3
• Start date: May 31, 2011
• Est. completion date: December 31, 2014

Study information

• Verified date: July 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 114
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Proctitis
• Proctocolitis
• Proctosigmoiditis
• Ulcer

Intervention

Drug:
• Budesonide Foam
Topical

Locations

Country	Name	City	State
United States	Gastroenterology Consultants, PA	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through up to Cycle 8 (Cycle=6 weeks)
Secondary	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.	Baseline and Cycle 4 (Cycle=6 weeks)
Secondary	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.	Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks)
Secondary	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.	Baseline through up to Cycle 8 (Cycle=6 weeks)