Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Open-label Trials to Evaluate the Long-term Safety and Tolerability of a New Balsalazide Disodium Tablet Formulation in Patients With Ulcerative Colitis

Conditions
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Inflammatory Bowel Disease, Ulcerative Colitis

Intervention / Treatment
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* Drug: Balsalazide Disodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: balsalazide disodium tablets,3.3 g BID,<br> | Drug: Balsalazide Disodium<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Emergent AEs | Incidence of treatment emergent adverse events | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Onset of AEs | Time to onset of adverse events | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, UC, Ulcerative Colitis, Inflammatory Bowel Disease