Balsalazide (DrugBank: Balsalazide)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 97 | Ulcerative colitis | 5 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00486031 (ClinicalTrials.gov) | October 2006 | 11/6/2007 | Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study | 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 | Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Balsalazide Disodium | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 443 | Phase 3 | United States |
| 2 | NCT00408174 (ClinicalTrials.gov) | May 2006 | 4/12/2006 | Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis | 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 | Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Balsalazide disodium | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 400 | Phase 3 | United States |
| 3 | NCT00269438 (ClinicalTrials.gov) | December 2005 | 22/12/2005 | New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis | 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 | Ulcerative Colitis | Drug: 5 ASA, enemas, suppositories, corticosteroids | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 80 Years | All | 225 | Phase 3 | United States |
| 4 | NCT00618202 (ClinicalTrials.gov) | May 2005 | 30/1/2008 | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions | Ulcerative Colitis | Drug: Balsalazide | Roxane Laboratories | NULL | Completed | 18 Years | 45 Years | All | 52 | N/A | United States |
| 5 | NCT00618228 (ClinicalTrials.gov) | January 2004 | 30/1/2008 | Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions | A Single Dose, Two-Period, Two-Treatment, Randomized Crossover Bioequivalency Study of 750 mg Balsalazide Capsules Under Fasting Conditions | Ulcerative Colitis | Drug: Balsalazide | Roxane Laboratories | NULL | Completed | 18 Years | 45 Years | All | 52 | N/A | United States |