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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00486031
First Posted: June 13, 2007
Last Update Posted: December 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Valeant Pharmaceuticals International, Inc.
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486031


  Show 95 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00486031     History of Changes
Other Study ID Numbers: BZUC3005
First Submitted: June 11, 2007
First Posted: June 13, 2007
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by Valeant Pharmaceuticals International, Inc.:
IBD
UC
Ulcerative Colitis
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
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
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents