Bausch Health Companies Inc.: Colitis, Ulcerative trials

The registry lists 15 Colitis, Ulcerative studies with Bausch Health Companies Inc. as lead sponsor. 2 are open to participants now and 7 have results posted.

Phase 1 1Phase 2 1Phase 3 11Phase 4 2(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative ColitisNot yet recruitingNCT05976802Phase 4
• Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative ColitisRecruitingNCT04314375Phase 4
• Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)CompletedNCT01532648Phase 3Results posted
• (CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release TabletsCompletedNCT01100112Phase 3Results posted
• (CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.CompletedNCT00801723Phase 3Results posted
• (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative ColitisCompletedNCT00679432Phase 3Results posted
• (CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative ColitisCompletedNCT00679380Phase 3Results posted
• Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis StudyCompletedNCT00486031Phase 3Results posted
• Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in RemissionCompletedNCT00326209Phase 3Results posted
• Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative ColitisCompletedNCT04857112Phase 2
• Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female SubjectsCompletedNCT03327558Phase 1
• Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative ColitisCompletedNCT00767728Phase 3
• Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative ColitisCompletedNCT00744016Phase 3
• Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative ColitisCompletedNCT00408174Phase 3
• New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative ColitisCompletedNCT00269438Phase 3