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Terminated for non-safety reasons when Sponsor felt that sufficient long-term safety data was obtained.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide Foam | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide Foam | Drug | Topical |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through up to Cycle 8 (Cycle=6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Consultants, PA | Houston | Texas | 77034 | United States |
Each participant received study drug for 6 weeks per cycle for up to 8 cycles and underwent a 48-hour study drug washout period between each cycle. Study was terminated for non-safety reasons when Sponsor felt sufficient long-term safety data was obtained.
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| ID | Title | Description |
|---|---|---|
| FG000 | Budesonide Foam | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Budesonide Foam | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline through up to Cycle 8 (Cycle=6 weeks) |
|
Baseline through up to Cycle 8 (Cycle=6 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Budesonide Foam | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenal insufficiency | Endocrine disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Companies | Lindsey.Mathew@bauschhealth.com |
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| ID | Term |
|---|---|
| D011349 | Proctitis |
| D011350 | Proctocolitis |
| D014456 | Ulcer |
| D003092 | Colitis |
| D003093 | Colitis, Ulcerative |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D003108 | Colonic Diseases |
| D012810 | Sigmoid Diseases |
| D010335 | Pathologic Processes |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baseline and Cycle 4 (Cycle=6 weeks) |
| 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. | Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks) |
| 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. | Baseline through up to Cycle 8 (Cycle=6 weeks) |
| Withdrawal by Subject |
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| Lost to Follow-up |
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| Adverse Event |
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| Study Terminated By Sponsor |
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| Lack of Efficacy |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | 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. | All participants who received at least 1 dose of study drug and with non-missing clinical laboratory parameter values at the specified timepoint. | Posted | Mean | Full Range | U/L | Baseline and Cycle 4 (Cycle=6 weeks) |
|
|
|
| Secondary | 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. | All participants who received at least 1 dose of study drug and with non-missing cortisol value at the specified timepoint. | Posted | Mean | Standard Deviation | nanomoles per liter (nmol/L) | Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks) |
|
|
|
| Secondary | 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. | All participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline through up to Cycle 8 (Cycle=6 weeks) |
|
|
|
| 0 |
| 114 |
| 66 |
| 114 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Anorectal discomfort | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Blood cortisol decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
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Please contact Sponsor directly for additional information.
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| Alanine Aminotransferase, Baseline |
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| Alanine Aminotransferase, Cycle 4 |
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| Lactate Dehydrogenase, Baseline |
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| Lactate Dehydrogenase, Cycle 4 |
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| Cycle 2, Day 15 |
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| Cycle 2, Day 42 |
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| Cycle 3, Day 15 |
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| Cycle 3, Day 42 |
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| Cycle 4, Day 15 |
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| Cycle 4, Day 42 |
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