Expired Study
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Houston, Texas 77034


Purpose:

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).


Study summary:

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.


Criteria:

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.


NCT ID:

NCT01349673


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Houston, Texas 77034
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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