ClinicalTrials.gov record
Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study
ClinicalTrials.gov ID: NCT00486031
Public ClinicalTrials.gov record NCT00486031. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00486031
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 443 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2006
- Primary completion
- Mar 31, 2008
- Completion
- Nov 30, 2008
- Last update posted
- Aug 14, 2019
2006 – 2008
United States locations
- U.S. sites
- 95
- U.S. states
- 32
- U.S. cities
- 85
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Gastroenterology Associates, PC | Birmingham | Alabama | 35209 | — |
| Premeire Pharmaceutical Research | Tempe | Arizona | 85282 | — |
| Medical Services of NWA | Fayetteville | Arkansas | 72703 | — |
| AGMG Clinical Research Institute | Anaheim | California | 92801 | — |
| Discovery Clinical Research, Inc. | Encinitas | California | 92024 | — |
| Digestive and Liver Disease Specialists | Garden Grove | California | 92840 | — |
| West Gastroenterology Medical Group | Los Angeles | California | 90045 | — |
| Community Clinical Trials | Orange | California | 92868 | — |
| Sharp Rees-Stealy Medical | San Diego | California | 92101 | — |
| Rocky Mountain Gastroenterology | Lakewood | Colorado | 80215 | — |
| Arapahoe Gastrroenterology, PC | Littleton | Colorado | 80120 | — |
| South Denver Gastroenterology | Lone Tree | Colorado | 80124 | — |
| Connecticut Gastroenterology Institute | Bristol | Connecticut | 06010 | — |
| Clinical Trials Management of Boca Raton | Boca Raton | Florida | 33486 | — |
| 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 | — |
| A+ Research | Miami | Florida | 33155 | — |
| United Medical Research | New Smyrna Beach | Florida | 32168 | — |
| Venture Research Institute, LLC | North Miami Beach | Florida | 33162 | — |
| West Wind'r Research & Development | Tampa | Florida | 33607 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Florida Medical Clinic, PA | Zephyrhills | Florida | 33542 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| Dekalb Gastroenterology Associates | Decatur | Georgia | 30033 | — |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | — |
| Digestive Research Associates | Newnan | Georgia | 30263 | — |
| University Digestive Health Center | Oak Forest | Illinois | 60452 | — |
| Carle Clinic Association | Urbana | Illinois | 61801 | — |
| Community Clinical Research Center | Anderson | Indiana | 46011 | — |
| Iowa Digestive Disease Center, PC | Clive | Iowa | 50325 | — |
| Cotton-O'Neil Digestive Health Center | Topeka | Kansas | 66606 | — |
| Digestive Health Center of Louisiana | Baton Rouge | Louisiana | 70809 | — |
| Clinical Trials Management | Metairie | Louisiana | 70006' | — |
| Digestive Disorders Associates | Annapolis | Maryland | 21401 | — |
| Alan Rosen, M.D. | Baltimore | Maryland | 21215 | — |
| Digestive Disease Association | Baltimore | Maryland | 21229 | — |
| Metro Gastroenterology Group | Chevy Chase | Maryland | 20815 | — |
| Washington County Hospital | Hagerstown | Maryland | 21740 | — |
| Philip J. Bean Medical Center | Hollywood | Maryland | 20636 | — |
| Charm City Research | Lutherville | Maryland | 21093 | — |
| Coastal Research Associates, Inc. | Braintree | Massachusetts | 02184 | — |
| Clinical Research Institute of Michigan LLC | Chesterfield | Michigan | 48047 | — |
| Gastroenterology Associates of West Michigan | Grand Rapids | Michigan | 49506 | — |
| Gastrointestinal Associates | Jackson | Mississippi | 39202 | — |
| Center for Digestive and Liver Diseases | Mexico | Missouri | 65265 | — |
| St. Louis Center for Clinical Research | St Louis | Missouri | 63128 | — |
| Central Jersey Medical Research | Elizabeth | New Jersey | 07202 | — |
| Shore Health Group | Ocean City | New Jersey | 07712 | — |
| The GI Group of South Jersey | Vineland | New Jersey | 08360 | — |
| Long Island Clinical Research | Great Neck | New York | 11021 | — |
| New York Presbyterian Hospital-Weill Medical College of Cornell University | New York | New York | 10021 | — |
| Simon Lichtiger, MD | New York | New York | 10128 | — |
| Stony Brook University Hospital | Stony Brook | New York | 11794-8173 | — |
| Charlotte Gastroenterology & Hepatology | Charlotte | North Carolina | 28207 | — |
| Northwest Piedmont Clinical Research | Elkin | North Carolina | 28621 | — |
| LeBauer Research Associates, PA | Greensboro | North Carolina | 27403 | — |
| Carolina Digestive Diseases, PA | Greenville | North Carolina | 27834 | — |
| East Carolina Gastroenterology, PA | Jacksonville | North Carolina | 28546 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Hanover Medical Specialists, PA | Wilmington | North Carolina | 28401 | — |
| Wilmington Gastroenterology Associates | Wilmington | North Carolina | 28403 | — |
| Digestive Health Specialists | Winston-Salem | North Carolina | 27103 | — |
| Gastroenterology Specialists, Inc. | Canton | Ohio | 44718 | — |
| Consultants for Clinical Research, Inc. | Cincinnati | Ohio | 45219 | — |
| Digestive Health Newtork | Cincinnati | Ohio | 45220 | — |
| Gastrointestinal & Liver Disease Consultants | Dayton | Ohio | 45410 | — |
| Avamar Center for Endoscopy | Warren | Ohio | 44484 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Gastroenterology United of Tulsa | Tulsa | Oklahoma | 74135 | — |
| George Koval, M.D. | Portland | Oregon | 97225 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Guthrie Clinic, Ltd | Sayre | Pennsylvania | 18840 | — |
| Charleston Gastroenterology Center | Charleston | South Carolina | 29414 | — |
| ClinSearch | Chattanooga | Tennessee | 37404 | — |
| Memphis Gastroenterology Group | Memphis | Tennessee | 38138 | — |
| Gastrointestinal Institute, PLLC | Nashville | Tennessee | 37203 | — |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | — |
| Austin Gastroenterology | Austin | Texas | 78745 | — |
| 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 | — |
| North Texas Gastroenterology | Lewisville | Texas | 75057 | — |
| Gastroenterology Clinic of San Antonio | San Antonio | Texas | 78229 | — |
| Advanced Research Institute | Ogden | Utah | 84405 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| McGuire VAMC | Richmond | Virginia | 23249 | — |
| Seattle Gastroenterology Associates | Seattle | Washington | 98133 | — |
| Tacoma Digestive Disease Research | Tacoma | Washington | 98405 | — |
| Discovery Research International | Milwaukee | Wisconsin | 53215 | — |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00486031, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 14, 2019 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00486031 live on ClinicalTrials.gov.