Back to resultsThe Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
Primary Purpose
Proctitis, Proctosigmoiditis
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Budesonide Foam
Sponsored by
About this trial
This is an interventional treatment trial for Proctitis focused on measuring Open-label, Proctitis, 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, Pharmacologic Actions, Anti-Asthmatic Agents, Respiratory System Agents, Therapeutic Uses, Glucocorticoids, Hormones, Hormones, Hormone Substitutes and Hormone Antagonists, Anti-inflammatory Agents
Eligibility 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.
Sites / Locations
- Gastroenterology Consultants, PA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Budesonide Foam
Arm Description
Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle.
Outcomes
Primary Outcome Measures
Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Secondary Outcome Measures
Clinically Notable Laboratory Parameters
Clinically notable laboratory parameters are defined as clinical laboratory values outside the reference range. Reference ranges for the clinical notable laboratory parameters: Aspartate Aminotransferase - 0-37 microliters (U/L); Alanine Aminotransferase - 0-47 U/L; Lactate Dehydrogenase - 110-250 U/L. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels
Fasting cortisol levels were evaluated, and cortisol was taken in the morning (AM cortisol) approximately 2 to 4 hours after waking. Data for cycles with more than 15 participants at the Cycle Baseline is reported.
Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline
A full or complete physical examination was performed at the Study Baseline. This physical examination included (but was not limited to): general appearance, head, ear, eyes, nose, throat, respiratory, cardiovascular, gastrointestinal, abdominal, neurological, lymphatic, dermatologic, and musculoskeletal. A symptom-directed physical examination was performed on Visit 2 (Day 1) to Visit 4 (Day 42) per Cycle (at the Investigator's discretion) and as needed for unscheduled clinic visits. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Full Information
NCT ID
NCT01349673
First Posted
May 4, 2011
Last Updated
July 19, 2019
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01349673
Brief Title
The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Terminated for non-safety reasons when Sponsor felt that sufficient long-term safety data was obtained.
Study Start Date
May 31, 2011 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proctitis, Proctosigmoiditis
Keywords
Open-label, Proctitis, 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, Pharmacologic Actions, Anti-Asthmatic Agents, Respiratory System Agents, Therapeutic Uses, Glucocorticoids, Hormones, Hormones, Hormone Substitutes and Hormone Antagonists, Anti-inflammatory Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Budesonide Foam
Arm Type
Experimental
Arm Description
Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle.
Intervention Type
Drug
Intervention Name(s)
Budesonide Foam
Intervention Description
Topical
Primary Outcome Measure Information:
Title
Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event
Description
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time Frame
Baseline through up to Cycle 8 (Cycle=6 weeks)
Secondary Outcome Measure Information:
Title
Clinically Notable Laboratory Parameters
Description
Clinically notable laboratory parameters are defined as clinical laboratory values outside the reference range. Reference ranges for the clinical notable laboratory parameters: Aspartate Aminotransferase - 0-37 microliters (U/L); Alanine Aminotransferase - 0-47 U/L; Lactate Dehydrogenase - 110-250 U/L. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time Frame
Baseline and Cycle 4 (Cycle=6 weeks)
Title
Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels
Description
Fasting cortisol levels were evaluated, and cortisol was taken in the morning (AM cortisol) approximately 2 to 4 hours after waking. Data for cycles with more than 15 participants at the Cycle Baseline is reported.
Time Frame
Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks)
Title
Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline
Description
A full or complete physical examination was performed at the Study Baseline. This physical examination included (but was not limited to): general appearance, head, ear, eyes, nose, throat, respiratory, cardiovascular, gastrointestinal, abdominal, neurological, lymphatic, dermatologic, and musculoskeletal. A symptom-directed physical examination was performed on Visit 2 (Day 1) to Visit 4 (Day 42) per Cycle (at the Investigator's discretion) and as needed for unscheduled clinic visits. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time Frame
Baseline through up to Cycle 8 (Cycle=6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Gastroenterology Consultants, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
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