The Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis
This study is currently recruiting participants.
Verified June 2012 by Salix Pharmaceuticals
Sponsor:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01349673
First received: May 4, 2011
Last updated: June 27, 2012
Last verified: June 2012
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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 |
| 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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349673
Contacts
| Contact: Melanie Klotz | 919-862-1000 | Melanie.Klotz@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: | June 27, 2012 |
| 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 May 21, 2013