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

Stopped early · Phase 3

Conditions studied: Proctitis, Proctosigmoiditis

In brief

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).

Key facts

Study ID

NCT01349673

Run by

Bausch Health Americas, Inc.

People needed

114

Starts

2011-05-31

Expected to finish

2014-12-31

Last updated by the study team

2019-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Gastroenterology Consultants, PA — Houston, Texas, United States

Full record on ClinicalTrials.gov

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