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

Primary Purpose

Inflammatory Bowel Disease, Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Balsalazide Disodium
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Disease focused on measuring IBD, UC, Ulcerative Colitis, Inflammatory Bowel Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Gastroenterology Associates, PC
  • Premeire Pharmaceutical Research
  • Medical Services of NWA
  • AGMG Clinical Research Institute
  • Discovery Clinical Research, Inc.
  • Digestive and Liver Disease Specialists
  • West Gastroenterology Medical Group
  • Community Clinical Trials
  • Sharp Rees-Stealy Medical
  • Rocky Mountain Gastroenterology
  • Arapahoe Gastrroenterology, PC
  • South Denver Gastroenterology
  • Connecticut Gastroenterology Institute
  • Clinical Trials Management of Boca Raton
  • Research Consultants Group
  • Horizon Institute for Clinical Research
  • Mark Lamet, M.D.
  • Southern Clinical Research Consultants
  • A+ Research
  • United Medical Research
  • Venture Research Institute, LLC
  • West Wind'r Research & Development
  • Shafran Gastroenterology Center
  • Florida Medical Clinic, PA
  • Atlanta Gastroenterology Associates
  • Dekalb Gastroenterology Associates
  • Gastroenterology Associates of Central Georgia
  • Digestive Research Associates
  • University Digestive Health Center
  • Carle Clinic Association
  • Community Clinical Research Center
  • Iowa Digestive Disease Center, PC
  • Cotton-O'Neil Digestive Health Center
  • Digestive Health Center of Louisiana
  • Clinical Trials Management
  • Digestive Disorders Associates
  • Alan Rosen, M.D.
  • Digestive Disease Association
  • Metro Gastroenterology Group
  • Washington County Hospital
  • Philip J. Bean Medical Center
  • Charm City Research
  • Coastal Research Associates, Inc.
  • Clinical Research Institute of Michigan LLC
  • Gastroenterology Associates of West Michigan
  • Gastrointestinal Associates
  • Center for Digestive and Liver Diseases
  • St. Louis Center for Clinical Research
  • Central Jersey Medical Research
  • Shore Health Group
  • The GI Group of South Jersey
  • Long Island Clinical Research
  • New York Presbyterian Hospital-Weill Medical College of Cornell University
  • Simon Lichtiger, MD
  • Stony Brook University Hospital
  • Charlotte Gastroenterology & Hepatology
  • Northwest Piedmont Clinical Research
  • LeBauer Research Associates, PA
  • Carolina Digestive Diseases, PA
  • East Carolina Gastroenterology, PA
  • Wake Research Associates
  • Hanover Medical Specialists, PA
  • Wilmington Gastroenterology Associates
  • Digestive Health Specialists
  • Gastroenterology Specialists, Inc.
  • Consultants for Clinical Research, Inc.
  • Digestive Health Newtork
  • Gastrointestinal & Liver Disease Consultants
  • Avamar Center for Endoscopy
  • Sooner Clinical Research
  • Gastroenterology United of Tulsa
  • George Koval, M.D.
  • Penn State Milton S. Hershey Medical Center
  • Thomas Jefferson University
  • Guthrie Clinic, Ltd
  • Charleston Gastroenterology Center
  • ClinSearch
  • Memphis Gastroenterology Group
  • Gastrointestinal Institute, PLLC
  • Nashville Medical Research Institute
  • Austin Gastroenterology
  • NationsMed Clinical Research
  • Houston Digestive Diseases Clinic
  • Houston Medical Research Associates
  • Baylor University Medical Center
  • North Texas Gastroenterology
  • Gastroenterology Clinic of San Antonio
  • Advanced Research Institute
  • Gastroenterology Associates of Tidewater
  • Digestive and Liver Disease Specialists
  • McGuire VAMC
  • Seattle Gastroenterology Associates
  • Tacoma Digestive Disease Research
  • Discovery Research International
  • Wisconsin Center for Advanced Research

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

balsalazide disodium tablets,3.3 g BID,

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent AEs
Incidence of treatment emergent adverse events

Secondary Outcome Measures

Time to Onset of AEs
Time to onset of adverse events

Full Information

First Posted
June 11, 2007
Last Updated
August 1, 2019
Sponsor
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00486031
Brief Title
Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Ulcerative Colitis
Keywords
IBD, UC, Ulcerative Colitis, Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
balsalazide disodium tablets,3.3 g BID,
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Balsalazide Disodium
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent AEs
Description
Incidence of treatment emergent adverse events
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Time to Onset of AEs
Description
Time to onset of adverse events
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Birmingham Gastroenterology Associates, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Premeire Pharmaceutical Research
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Medical Services of NWA
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
AGMG Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Discovery Clinical Research, Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
West Gastroenterology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sharp Rees-Stealy Medical
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Rocky Mountain Gastroenterology
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Arapahoe Gastrroenterology, PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
South Denver Gastroenterology
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Connecticut Gastroenterology Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Clinical Trials Management of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Research Consultants Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Facility Name
Horizon Institute for Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mark Lamet, M.D.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Southern Clinical Research Consultants
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
A+ Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
United Medical Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Venture Research Institute, LLC
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
West Wind'r Research & Development
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Florida Medical Clinic, PA
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Dekalb Gastroenterology Associates
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Digestive Research Associates
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
University Digestive Health Center
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
Carle Clinic Association
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Community Clinical Research Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Iowa Digestive Disease Center, PC
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Cotton-O'Neil Digestive Health Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Digestive Health Center of Louisiana
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Clinical Trials Management
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006'
Country
United States
Facility Name
Digestive Disorders Associates
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Alan Rosen, M.D.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Digestive Disease Association
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Metro Gastroenterology Group
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Washington County Hospital
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Philip J. Bean Medical Center
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
Charm City Research
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Coastal Research Associates, Inc.
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02184
Country
United States
Facility Name
Clinical Research Institute of Michigan LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Gastroenterology Associates of West Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Gastrointestinal Associates
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Center for Digestive and Liver Diseases
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Central Jersey Medical Research
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
Country
United States
Facility Name
Shore Health Group
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
The GI Group of South Jersey
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Long Island Clinical Research
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
New York Presbyterian Hospital-Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Simon Lichtiger, MD
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8173
Country
United States
Facility Name
Charlotte Gastroenterology & Hepatology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Northwest Piedmont Clinical Research
City
Elkin
State/Province
North Carolina
ZIP/Postal Code
28621
Country
United States
Facility Name
LeBauer Research Associates, PA
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Carolina Digestive Diseases, PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
East Carolina Gastroenterology, PA
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Hanover Medical Specialists, PA
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Wilmington Gastroenterology Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Digestive Health Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Gastroenterology Specialists, Inc.
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Consultants for Clinical Research, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Digestive Health Newtork
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Gastrointestinal & Liver Disease Consultants
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45410
Country
United States
Facility Name
Avamar Center for Endoscopy
City
Warren
State/Province
Ohio
ZIP/Postal Code
44484
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Gastroenterology United of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
George Koval, M.D.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Guthrie Clinic, Ltd
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Charleston Gastroenterology Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
ClinSearch
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Gastrointestinal Institute, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Austin Gastroenterology
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
NationsMed Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Houston Digestive Diseases Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Houston Medical Research Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Baylor University Medical Center
City
Irving
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
North Texas Gastroenterology
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75057
Country
United States
Facility Name
Gastroenterology Clinic of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
McGuire VAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Seattle Gastroenterology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Tacoma Digestive Disease Research
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Discovery Research International
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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