ClinicalTrials.gov record
Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis
ClinicalTrials.gov ID: NCT00408174
Public ClinicalTrials.gov record NCT00408174. 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, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 6 weeks of therapy.
Study identification
- NCT ID
- NCT00408174
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 400 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
- May 2006 (Type not available)
- Primary completion
- Jul 2007 (Actual)
- Completion
- Nov 2007 (Actual)
- Last update posted
- Nov 25, 2019
2006 – 2007
United States locations
- U.S. sites
- 88
- U.S. states
- 31
- U.S. cities
- 77
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Premiere Pharmaceutical Research | Tempe | Arizona | 85282 | — |
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | — |
| Medical Services of Northwest Arkansas | Fayetteville | Arkansas | 72703 | — |
| Gastroenterology Associates | Little Rock | Arkansas | 72205 | — |
| AGMG Clinical Research Institute | Anaheim | California | 92801 | — |
| West Gastroenterology Medical Group | Los Angeles | California | 90045 | — |
| Sharp Rees-Stealy Medical Group | San Diego | California | 92101 | — |
| Rocky Mountain Gastroenterology | Lakewood | Colorado | 80215 | — |
| Arapahoe Gastroenterology, PC | Littleton | Colorado | 80120 | — |
| South Denver Gastroenterology | Lone Tree | Colorado | 80124 | — |
| Phoenix Internal Medical Associates | Waterbury | Connecticut | 06708 | — |
| Clinical Trials Management of Bocal Raton | Boca Raton | Florida | 33486 | — |
| Research Consultants Group | Hialeah | Florida | 33016 | — |
| Horizon Institute for Clinical Researcg | Hollywood | Florida | 33021 | — |
| Mark Lamet, M.D. | Hollywood | Florida | 33021 | — |
| Borland-Grover Clinic | Jacksonville | Florida | 32256 | — |
| A+ Research | Miami | Florida | 33155 | — |
| West Wind'r Research & Development | Tampa | Florida | 33607 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Florida Medical Clinic | Zephyrhills | Florida | 33542 | — |
| The Atlanta Center for Gastroenterology | Atlanta | Georgia | 30033 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| Atlanta Academic Research | Decatur | Georgia | 30033 | — |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | — |
| Digestive Research Associates | Newnan | Georgia | 30263 | — |
| University of Illinois at Chicago | Chicago | Illinois | 80120 | — |
| Carle Clinic Association | Urbana | Illinois | 61801 | — |
| Community Clinical Research Center | Anderson | Indiana | 46011 | — |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | — |
| Clinical Trials Management | Metairie | Louisiana | 70006 | — |
| Digestive Disorders Association | Annapolis | Maryland | 21401 | — |
| Maryland Clinical Trials | Annapolis | Maryland | 21401 | — |
| Alan Rosen, M.D. | Baltimore | Maryland | 21215 | — |
| Digestive Disease Associates | Baltimore | Maryland | 21229 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| The Center for Clinical Research | Hagerstown | Maryland | 21740 | — |
| Charm City Research | Lutherville | Maryland | 21093 | — |
| Coastal Research Associates | Braintree | Massachusetts | 02184 | — |
| Gastroenterology Associates of Western Michigan | Grand Rapids | Michigan | 49506 | — |
| Borgess Research Institute | Kalamazoo | Michigan | 49048 | — |
| Henry Ford West Bloomfield | West Bloomfield | Michigan | 48322 | — |
| Gastrointestinal Associates | Jackson | Mississippi | 39202 | — |
| Center for Digestive and Liver Diseases | Mexico | Missouri | 65265 | — |
| The GI Group of South Jersey | Vineland | New Jersey | 08360 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| Long Island Clinical | Great Neck | New York | 11021 | — |
| New York Center for Clinical Research | Lake Success | New York | 11042 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| Reseach Associates of NY | New York | New York | 10021 | — |
| Simon Lichtiger, M.D. | New York | New York | 10128 | — |
| Asheville Gastroenterology | Asheville | North Carolina | 28801 | — |
| Charlotte Gastroenterology & Hematology, PLLC | Charlotte | North Carolina | 28207 | — |
| Carolina Digestive Health Associates | Charlotte | North Carolina | 28211 | — |
| Northwest Piedmont Clinical Research | Elkin | North Carolina | 28621 | — |
| Carolina Research Center | Greenville | North Carolina | 27834 | — |
| East Carolina Gastroenterology | Jacksonville | North Carolina | 28546 | — |
| Wake Research Associates, LLC | 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 | — |
| Digestive Health Network | Cincinnati | Ohio | 45220 | — |
| Gastrointestinal & Liver Diseases Consultants, PC | Dayton | Ohio | 45440 | — |
| AvamarCenter for Endoscopy | Warren | Ohio | 44484 | — |
| Sooner Clinical Research | Oklahoma City | Oklahoma | 73112 | — |
| Gastroenterology United of Tulsa | Tulsa | Oklahoma | 74135 | — |
| West Hills Gastroenterology | Portland | Oregon | 97225 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Guthrie | Sayre | Pennsylvania | 18840 | — |
| Charleston Gastroenterology Center | Charleston | South Carolina | 29414 | — |
| MUSC Digestive Disease Center | Charleston | South Carolina | 29425 | — |
| Clin Search | Chattanooga | Tennessee | 37404 | — |
| ACE Research Specialists | Hermitage | Tennessee | 37067 | — |
| Gastrointestinal Instititute PLLC | Nashville | Tennessee | 37203 | — |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | — |
| Austin Gastroenterology | Austin | Texas | 78745 | — |
| Houston Digestive Diseases Clinci | Houston | Texas | 77090 | — |
| Houston Medical Research Associates | Houston | Texas | 77090 | — |
| 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 | — |
| Liver and Digestive Disease Specialists | Norfolk | Virginia | 23502 | — |
| McGuire VAMC | Richmond | Virginia | 23249 | — |
| 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 NCT00408174, 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 Nov 25, 2019 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00408174 live on ClinicalTrials.gov.