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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Salix Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01349673
First received: May 4, 2011
Last updated: March 24, 2014
Last verified: March 2014

May 4, 2011
March 24, 2014
June 2011
February 2015   (final data collection date for primary outcome measure)
To evaluate safety and tolerability of cyclically dosed rectal budesonide foam in subjects who present with a diagnosis of active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

The following safety endpoints will be assessed throughout the study for each treatment group:

  • Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), grouped by body system, relationship to study medication, and severity.
  • Changes from baseline in clinical laboratory assessments: urinalysis, hematology, and clinical chemistry.
  • Changes from baseline in vital sign assessments.
  • Changes from baseline in physical examination findings.
Same as current
Complete list of historical versions of study NCT01349673 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis
A Phase 3, Open Label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis

The purpose of this study is to evaluate safety and tolerability of cyclically dosed rectal budesonide foam in subjects with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).

This is a Phase 3, multicenter, open label study in subjects who have participated previously in a Salix-sponsored budesonide rectal foam study for the treatment of ulcerative proctitis or proctosigmoiditis. Approximately 300 subjects will be enrolled into the study and receive budesonide foam cyclically for 6 weeks (BID for 2 weeks and QD for 4 weeks) each time they have an ulcerative proctitis or proctosigmoiditis flare. The study will continue until regulatory approval of budesonide foam occurs, or the sponsor decides to terminate the study.

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Proctitis
  • Proctosigmoiditis
Drug: Budesonide Foam
2mg/25ml BID for 2 weeks followed by 2mg/25ml QD for 4weeks
Experimental: Budesonide foam
2mg/25ml BID for 2 weeks followed by 2mg/25ml QD for 4weeks
Intervention: Drug: Budesonide Foam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or non-pregnant, non breast-feeding females ≥ 18 years old.
  • Subject has previously been diagnosed with active mild to moderate UP/UPS and is currently experiencing symptoms of active UP/UPS disease after having completed participation in Salix's BUCF3001 or BUCF3002 study.
  • Willingness to undergo sigmoidoscopy.

Exclusion Criteria:

  • Active systemic, ocular or cutaneous infection (e.g., parasitic, fungal, amoebic, viral or bacterial disease).
  • History of sclerosing cholangitis, cirrhosis, or hepatic impairment, including chronic hepatitis of any etiology.
  • Subject has taken systemic, inhaled, oral, topical or rectal corticosteroids (other than budesonide rectal foam) within 7 days of starting a treatment cycle.
  • Subject has taken ketoconazole and other potent CYP3A4 inhibitors within 7 days of starting a treatment cycle.
  • Subjects who take diuretics with cardiac glycosides.
  • Unstable significant cardiovascular, hepatic, renal, endocrine, neurologic or pulmonary disease.
Both
18 Years and older
No
Contact: Chantelle McGee 919-447-3176 chantelle.mcgee@salix.com
United States
 
NCT01349673
BFPS3073
No
Salix Pharmaceuticals
Salix Pharmaceuticals
Not Provided
Not Provided
Salix Pharmaceuticals
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP