Inflammatory Bowel DiseasePhase 3NCT00486031
Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
A Phase 3 study testing Balsalazide Disodium in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by Bausch Health Americas, Inc. at 95 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Ulcerative Colitis
- What is being tested?
- Balsalazide Disodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 95 sitesUnited States
- Study dates
- Oct 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
95 sites in 1 country.
95 sites in 1 country
United States95 sites
AGMG Clinical Research Institute
Anaheim, California, 92801
Community Clinical Research Center
Anderson, Indiana, 46011
Digestive Disorders Associates
Annapolis, Maryland, 21401
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Austin Gastroenterology
Austin, Texas, 78745
Alan Rosen, M.D.
Baltimore, Maryland, 21215
Digestive Disease Association
Baltimore, Maryland, 21229
Digestive Health Center of Louisiana
Baton Rouge, Louisiana, 70809
Birmingham Gastroenterology Associates, PC
Birmingham, Alabama, 35209
Clinical Trials Management of Boca Raton
Boca Raton, Florida, 33486
Coastal Research Associates, Inc.
Braintree, Massachusetts, 02184
Connecticut Gastroenterology Institute
Bristol, Connecticut, 06010
Gastroenterology Specialists, Inc.
Canton, Ohio, 44718
Charleston Gastroenterology Center
Charleston, South Carolina, 29414
Charlotte Gastroenterology & Hepatology
Charlotte, North Carolina, 28207
ClinSearch
Chattanooga, Tennessee, 37404
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Clinical Research Institute of Michigan LLC
Chesterfield, Michigan, 48047
Metro Gastroenterology Group
Chevy Chase, Maryland, 20815
Consultants for Clinical Research, Inc.
Cincinnati, Ohio, 45219
Digestive Health Newtork
Cincinnati, Ohio, 45220
Iowa Digestive Disease Center, PC
Clive, Iowa, 50325
Gastrointestinal & Liver Disease Consultants
Dayton, Ohio, 45410
Dekalb Gastroenterology Associates
Decatur, Georgia, 30033
Central Jersey Medical Research
Elizabeth, New Jersey, 07202
Northwest Piedmont Clinical Research
Elkin, North Carolina, 28621
Discovery Clinical Research, Inc.
Encinitas, California, 92024
Medical Services of NWA
Fayetteville, Arkansas, 72703
Digestive and Liver Disease Specialists
Garden Grove, California, 92840
Gastroenterology Associates of West Michigan
Grand Rapids, Michigan, 49506
Long Island Clinical Research
Great Neck, New York, 11021
LeBauer Research Associates, PA
Greensboro, North Carolina, 27403
Carolina Digestive Diseases, PA
Greenville, North Carolina, 27834
Washington County Hospital
Hagerstown, Maryland, 21740
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Research Consultants Group
Hialeah, Florida, 33010
Horizon Institute for Clinical Research
Hollywood, Florida, 33021
Mark Lamet, M.D.
Hollywood, Florida, 33021
Southern Clinical Research Consultants
Hollywood, Florida, 33021
Philip J. Bean Medical Center
Hollywood, Maryland, 20636
NationsMed Clinical Research
Houston, Texas, 77036
Houston Digestive Diseases Clinic
Houston, Texas, 77090
Houston Medical Research Associates
Houston, Texas, 77090
Baylor University Medical Center
Irving, Texas, 75601
Gastrointestinal Associates
Jackson, Mississippi, 39202
East Carolina Gastroenterology, PA
Jacksonville, North Carolina, 28546
Rocky Mountain Gastroenterology
Lakewood, Colorado, 80215
North Texas Gastroenterology
Lewisville, Texas, 75057
Arapahoe Gastrroenterology, PC
Littleton, Colorado, 80120
South Denver Gastroenterology
Lone Tree, Colorado, 80124
West Gastroenterology Medical Group
Los Angeles, California, 90045
Charm City Research
Lutherville, Maryland, 21093
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201
Memphis Gastroenterology Group
Memphis, Tennessee, 38138
Clinical Trials Management
Metairie, Louisiana, 70006'
Center for Digestive and Liver Diseases
Mexico, Missouri, 65265
A+ Research
Miami, Florida, 33155
Discovery Research International
Milwaukee, Wisconsin, 53215
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Gastrointestinal Institute, PLLC
Nashville, Tennessee, 37203
Nashville Medical Research Institute
Nashville, Tennessee, 37205
United Medical Research
New Smyrna Beach, Florida, 32168
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, 10021
Simon Lichtiger, MD
New York, New York, 10128
Digestive Research Associates
Newnan, Georgia, 30263
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Venture Research Institute, LLC
North Miami Beach, Florida, 33162
University Digestive Health Center
Oak Forest, Illinois, 60452
Shore Health Group
Ocean City, New Jersey, 07712
Advanced Research Institute
Ogden, Utah, 84405
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
Community Clinical Trials
Orange, California, 92868
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
George Koval, M.D.
Portland, Oregon, 97225
Wake Research Associates
Raleigh, North Carolina, 27612
McGuire VAMC
Richmond, Virginia, 23249
Gastroenterology Clinic of San Antonio
San Antonio, Texas, 78229
Sharp Rees-Stealy Medical
San Diego, California, 92101
Guthrie Clinic, Ltd
Sayre, Pennsylvania, 18840
Seattle Gastroenterology Associates
Seattle, Washington, 98133
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
Stony Brook University Hospital
Stony Brook, New York, 11794-8173
Tacoma Digestive Disease Research
Tacoma, Washington, 98405
West Wind'r Research & Development
Tampa, Florida, 33607
Premeire Pharmaceutical Research
Tempe, Arizona, 85282
Cotton-O'Neil Digestive Health Center
Topeka, Kansas, 66606
Gastroenterology United of Tulsa
Tulsa, Oklahoma, 74135
Carle Clinic Association
Urbana, Illinois, 61801
The GI Group of South Jersey
Vineland, New Jersey, 08360
Avamar Center for Endoscopy
Warren, Ohio, 44484
Hanover Medical Specialists, PA
Wilmington, North Carolina, 28401
Wilmington Gastroenterology Associates
Wilmington, North Carolina, 28403
Digestive Health Specialists
Winston-Salem, North Carolina, 27103
Shafran Gastroenterology Center
Winter Park, Florida, 32789
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542
About this 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
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.
Read the 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.
- Conditions
- Inflammatory Bowel Disease, Ulcerative Colitis
- Being tested
- Balsalazide Disodium
- Keywords
- IBD, UC, Ulcerative Colitis, Inflammatory Bowel Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balsalazide DisodiumDrug
| Study group | Role | What they receive |
|---|---|---|
| balsalazide disodium tablets,3.3 g BID, | Other | Not described Receives: Drug: Balsalazide Disodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent AEs
Incidence of treatment emergent adverse events
Measured: 24 Months
Secondary outcomes (1)
Time to Onset of AEs
Time to onset of adverse events
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startOct 2006
- Primary completionApr 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486031
- Sponsor's protocol ID
- BZUC3005
- Status last verified
- Aug 2019
- First submitted
- 11 Jun 2007
- Last updated
- 15 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00486031
- Acronym / sponsor ID
- BZUC3005
- Conditions
- Inflammatory Bowel Disease, Ulcerative Colitis
- Keywords
- IBD, UC, Ulcerative Colitis, Inflammatory Bowel Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Jun 2007 (estimated)
- Results
- Posted 19 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| balsalazide disodium tablets,3.3 g BID, | Other | Drug: Balsalazide Disodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balsalazide Disodium | Drug | balsalazide disodium tablets,3.3 g BID, |
Primary outcome
Incidence of Treatment Emergent AEs
Time frame: 24 Months
Incidence of treatment emergent adverse events
1 secondary outcome
Time to Onset of AEs
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
95 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Balsalazide Disodium in people with Inflammatory Bowel Disease and Ulcerative Colitis, run by Bausch Health Americas, Inc. at 95 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent AEs (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.