Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
This study has been completed.
Information provided by:
First received: June 11, 2007
Last updated: December 21, 2009
Last verified: December 2009
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.
Inflammatory Bowel Disease
Drug: Balsalazide Disodium
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Incidence of adverse events and serious adverse events,relationship to study medication, and severity
Secondary Outcome Measures:
- Time to onset of adverse events
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2008 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486031
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 11, 2007
||December 21, 2009
||United States: Food and Drug Administration
Keywords provided by Salix Pharmaceuticals:
Inflammatory Bowel Disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Inflammatory Bowel Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents