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

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00486031
First received: June 11, 2007
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Inflammatory Bowel Disease
Ulcerative Colitis
 Drug: Balsalazide Disodium
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

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: 500
Study Start Date: October 2006
Study Completion Date: December 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486031

  Show 95 Study Locations
Sponsors and Collaborators
Salix Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00486031     History of Changes
Other Study ID Numbers: BZUC3005
Study First Received: June 11, 2007
Last Updated: December 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
IBD
UC
Ulcerative Colitis
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Balsalazide
Mesalamine
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013