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The primary objective of this study is to evaluate the efficacy (as measured by induction of remission) of two dose levels (low and high) per age group (5 to <12 and 12 to ≤17 years) of budesonide rectal foam as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in pediatric subjects with active, mild to moderate distal ulcerative colitis (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose budesonide rectal foam | Experimental |
| |
| Low dose budesonide rectal foam | Experimental |
| |
| Matching placebo rectal foam | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose budesonide rectal foam | Drug | Twice a day for 2 weeks, then once a day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with clinical remission | Clinical remission based on the modified Mayo Clinic Score, defined as an endoscopy score ≤ 1 (excluding friability), a rectal bleeding subscore of 0, and at least a 1-point decrease in stool frequency subscore from Baseline to achieve a stool frequency subscore ≤ 1. Each component is scored from 0 to 3, with total scores ranging from 0 to 9, with higher scores indicating more severe disease. | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieve a rectal bleeding subscale score of 0 at the end of six weeks of treatment | Scored from 0 to 3, with higher scores indicating more severe disease. | Day 42 |
| Proportion of participants who achieve a stool frequency subscale score of 0 at the end of six weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
Current or prior diagnosis of Crohn's disease or indeterminate colitis.
Ulcerative colitis involving the proximal colon - i.e, the sigmoid, left, transverse, and/or ascending colon and cecum;
Severe UC, defined as an mMCS > 8.
Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days of Screening).
Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical).
NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to Screening.
Evidence or history of toxic megacolon or bowel resection.
Active proctologic pathology such as hemorrhoids, fistulas and fissures or other historical anatomic problems which would impair rectal administration (e.g., cloaca, imperforate anus history)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Varsha Bhatt | Contact | 707-285-1528 | Varsha.Bhatt@bauschhealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Varsha Bhatt | Bausch Health Americas, Inc. | Study Director |
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| Low dose budesonide rectal foam | Drug | Twice a day for 2 weeks, then once a day for 4 weeks |
|
| Matching placebo rectal foam | Drug | Twice a day for 2 weeks, then once a day for 4 weeks |
|
Scored from 0 to 3, with higher scores indicating more severe disease. |
| Day 42 |
| Proportion of subjects who achieve an endoscopy subscale score of 0 or 1 at the end of six weeks of treatment. | Scored from 0 to 3, with higher scores indicating more severe disease. | Day 42 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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