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
  Purpose

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).


Condition Intervention Phase
Proctitis
Proctosigmoiditis
Drug: Budesonide Foam
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: June 2011
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Budesonide foam
2mg/25ml BID for 2 weeks followed by 2mg/25ml QD for 4weeks
Drug: Budesonide Foam
2mg/25ml BID for 2 weeks followed by 2mg/25ml QD for 4weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349673

Contacts
Contact: Chantelle McGee 919-447-3176 chantelle.mcgee@salix.com

Locations
United States, Texas
Gastroenterology Consultants, PA Recruiting
Houston, Texas, United States, 77034
Sponsors and Collaborators
Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01349673     History of Changes
Other Study ID Numbers: BFPS3073
Study First Received: May 4, 2011
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Proctitis
Open-label
Proctosigmoiditis
Ulcerative
Salix
Budesonide foam
Budesonide
Rectal
Gastrointestinal
Colitis
UC
UP
UPS
Additional relevant MeSH terms:
Proctocolitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Colonic Diseases
Sigmoid Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Additional relevant MeSH terms:
Proctitis
Proctocolitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Sigmoid Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents
Budesonide
Bronchodilator Agents
Anti-Asthmatic Agents
Peripheral Nervous System Agents
Respiratory System Agents
Physiological Effects of Drugs
Therapeutic Uses
Pharmacologic Actions
Autonomic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 24, 2014