Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
IBD, UC, Ulcerative Colitis, Inflammatory Bowel Disease
Brief summary
The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.
Detailed description
The objective of the study is to evaluate the long-term safety and tolerability of treatment with balsalazide disodium tablets in subjects who are in remission from ulcerative colitis or who have mildly to moderately active UC.
Interventions
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has a documented history of UC and is either in remission or currently presents with mildly to moderately active UC symptoms as determined by the investigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency, and rectal bleeding). Additionally, the diagnosis of UC must be confirmed by past flexible sigmoidoscopy/colonoscopy which may include colonic mucosal pathological findings on biopsy consistent with UC. * Subject is capable and willing to comply with all study procedures.
Exclusion criteria
* Subject has a history of allergy or intolerance to aspirin, mesalamine or other salicylates. * Subject has participated in an investigational drug or device study, other than a previous balsalazide disodium tablet trial (i.e., BZUC3002 or BZUC3003), within 30 days of entering the current study. * Subject discontinued from a previous balsalazide disodium tablet study due to study drug-related AE(s), including UC flare or associated symptoms that were perceived by the subject/investigator as being caused by study drug. * Subject has had any prior bowel surgery, except appendectomy and cholecystectomy. * Subject has unstable cardiovascular, coagulopathy, or pulmonary disease. * Regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) except cardioprotective ASA (i.e., less than or equal to 162 mg ASA per day). * Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C). Subjects with a history of hepatitis B and C will be eligible provided the screening LFTs are within normal limits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent AEs | 24 Months | Incidence of treatment emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Onset of AEs | 24 Months | Time to onset of adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balsalazide Disodium Tabs,3.3 g BID, balsalazide disodium tablets,3.3 g BID, | 440 |
| Total | 440 |
Baseline characteristics
| Characteristic | Balsalazide Disodium Tabs,3.3 g BID, |
|---|---|
| Age, Customized <65 years | 412 Participants |
| Age, Customized >=65 years | 28 Participants |
| Sex: Female, Male Female | 216 Participants |
| Sex: Female, Male Male | 224 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 273 / 440 |
| serious Total, serious adverse events | 21 / 440 |
Outcome results
Primary
Incidence of Treatment Emergent AEs
Incidence of treatment emergent adverse events
Time frame: 24 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Balsalazide Disodium | Incidence of Treatment Emergent AEs | 273 participants |
Secondary
Time to Onset of AEs
Time to onset of adverse events
Time frame: 24 Months
Population: Data were not collected to perform this analysis