New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT00269438. 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
Phase 3 Study 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 8 Weeks of Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is 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 8 weeks of therapy.
Study identification
- NCT ID
- NCT00269438
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2005 (Type not available)
- Primary completion
- Mar 2007 (Actual)
- Completion
- Jun 2007 (Actual)
- Last update posted
- Nov 25, 2019
2005 – 2007
United States locations
- U.S. sites
- 66
- U.S. states
- 23
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham Gastroenterology Associates | Birmingham | Alabama | 35209 | — |
| Spring Memorial Hospital | Mobile | Alabama | 36608 | — |
| Little Rock Diagnostic Clinic | Little Rock | Arkansas | 72205 | — |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | — |
| Lovelace Scientific Resources | Beverly Hills | California | 90211 | — |
| Digestive Liver Disease Specialists, Medical Group | Garden Grove | California | 92840 | — |
| Therapeutic Research Institute of Orange County | Laguna Hills | California | 92653 | — |
| Long Beach VA Medical Center | Long Beach | California | 90822 | — |
| Facey Medical Group | Mission Hills | California | 91345 | — |
| Community Clinical Trials | Orange | California | 92868 | — |
| Rider Research Group | San Francisco | California | 94117 | — |
| John Jolley, M.D. | San Rafael | California | 94901 | — |
| Lovelace Scientific Resources | Santa Ana | California | 92704 | — |
| Santa Barbara Clinical Research | Santa Barbara | California | 93108 | — |
| Connecticut Gastroenterology Institute | Bristol | Connecticut | 06010 | — |
| Stamford Therapeutic Consortium | Stamford | Connecticut | 06905 | — |
| Medical Research Unlimited | Hialeah | Florida | 33013 | — |
| Mark Lamet, M.D. | Hollywood | Florida | 33021 | — |
| Southern Clinical Research Consultants | Hollywood | Florida | 33021 | — |
| United Medical Research | New Smyrna Beach | Florida | 32168 | — |
| Venture Research Institute, LLC | North Miami Beach | Florida | 33162 | — |
| Advanced Gastroenterology Associates | Palm Harbor | Florida | 34684 | — |
| Lovelace Scientific Resources | Sarasota | Florida | 34233 | — |
| Advent Clinical Research | Sarasota | Florida | 34239 | — |
| Clinical Research of Tampa Bay, Inc. | Spring Hill | Florida | 34609 | — |
| Metabolic Research Institute, Inc. | West Palm Beach | Florida | 33401 | — |
| Gary Richter, M.D. | Atlanta | Georgia | 30308 | — |
| The Atlanta Center for Gastroenterology | Decatur | Georgia | 30033 | — |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | — |
| Northwest Gastroenterologists S.C. | Arlington Heights | Illinois | 60005 | — |
| University Digestive Health Center | Oak Forest | Illinois | 60452 | — |
| Covenent Clinic | Waterloo | Iowa | 50702 | — |
| Digestive Health Center | Topeka | Kansas | 66606 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Digestive Health Center of Louisiana | Baton Rouge | Louisiana | 70809 | — |
| Woodholme Gastroenterology Associates, PA | Baltimore | Maryland | 21208 | — |
| Sinai Medical Office Building | Baltimore | Maryland | 21215 | — |
| Mid Atlantic Medical Research Centers | Hollywood | Maryland | 20636 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Not listed | Kansas City | Missouri | 67131 | — |
| Center for Digestive & Liver Diseases | Mexico | Missouri | 65265 | — |
| St. Louis Center for Clinical Research | St Louis | Missouri | 63128 | — |
| Central Jersey Primary Care Inc. | Elizabeth | New Jersey | 07202 | — |
| Not listed | Ocean City | New Jersey | 07712 | — |
| Not listed | New York | New York | 10128 | — |
| VA Medical Center | Syracuse | New York | 13210 | — |
| Upstate Gastroenterology Associates, PC | Troy | New York | 12180 | — |
| LeBauer Research Associates, PA | Greensboro | North Carolina | 27265 | — |
| Bethany Medical Center | High Point | North Carolina | 27262 | — |
| Boice-Willis Clinic | Rocky Mount | North Carolina | 27804 | — |
| Consultants for Clinical Research, Inc. | Cincinnati | Ohio | 45219 | — |
| Avamar Center for Gastroenterology, Inc. | Warren | Ohio | 44484 | — |
| Charleston Gastroenterology Specialists, LLC | Charleston | South Carolina | 29414 | — |
| Hillcrest Clinical Research LLC | Simpsonville | South Carolina | 29681 | — |
| Gastroenterology Associates | Kingsport | Tennessee | 37660 | — |
| Gastrointestinal Associates | Knoxville | Tennessee | 37909 | — |
| Memphis Gastroenterology Group | Memphis | Tennessee | 38210 | — |
| Nashville Medical Research Institute | Nashville | Tennessee | 37205 | — |
| Clinical Trial Network | Houston | Texas | 77030 | — |
| NationsMed Clinical Research | Houston | Texas | 77034 | — |
| Houston Digestive Disease Clinic | Houston | Texas | 77090 | — |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | — |
| Seattle Gastroenterology Associates | Seattle | Washington | 98133 | — |
| Eastern Washington Clinical Research Center | Spokane | Washington | 99204 | — |
| Spokane Digestive Disease Center Research | Spokane | Washington | 99204 | — |
| Tacoma Digestive Disease Research Center | Tacoma | Washington | 98405 | — |
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 NCT00269438, 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 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00269438 live on ClinicalTrials.gov.