CLINICAL TRIALS PROFILE FOR BALSALAZIDE DISODIUM

All Clinical Trials for BALSALAZIDE DISODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00269438 ↗	New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis	Completed	Bausch Health Americas, Inc.	Phase 3	2005-12-01	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.
NCT00269438 ↗	New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2005-12-01	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.
NCT00408174 ↗	Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis	Completed	Bausch Health Americas, Inc.	Phase 3	2006-05-01	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.
NCT00408174 ↗	Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2006-05-01	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.
NCT00486031 ↗	Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study	Completed	Bausch Health Americas, Inc.	Phase 3	2006-10-01	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.
NCT00486031 ↗	Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2006-10-01	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.
NCT00618202 ↗	A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions	Completed	Roxane Laboratories	N/A	2005-05-01	The objective of this study was to assess the bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, administered under fasting conditions.

Clinical Trial Conditions for BALSALAZIDE DISODIUM

Condition Name

Condition Name for BALSALAZIDE DISODIUM
Intervention	Trials
Ulcerative Colitis	5
Healthy	2
Inflammatory Bowel Disease	2

Condition MeSH

Condition MeSH for BALSALAZIDE DISODIUM
Intervention	Trials
Colitis, Ulcerative	5
Colitis	3
Ulcer	3
Intestinal Diseases	2

Clinical Trial Locations for BALSALAZIDE DISODIUM

Trials by Country

Trials by Country for BALSALAZIDE DISODIUM
Location	Trials
United States	90

Trials by US State

Trials by US State for BALSALAZIDE DISODIUM
Location	Trials
Texas	5
Connecticut	3
California	3
Arkansas	3
Virginia	3

Clinical Trial Progress for BALSALAZIDE DISODIUM

Clinical Trial Phase

Clinical Trial Phase for BALSALAZIDE DISODIUM
Clinical Trial Phase	Trials
Phase 3	3
Phase 1	2
N/A	2

Clinical Trial Status

Clinical Trial Status for BALSALAZIDE DISODIUM
Clinical Trial Phase	Trials
Completed	7

Clinical Trial Sponsors for BALSALAZIDE DISODIUM

Sponsor Name

Sponsor Name for BALSALAZIDE DISODIUM
Sponsor	Trials
Bausch Health Americas, Inc.	3
Valeant Pharmaceuticals International, Inc.	3
Roxane Laboratories	2

Sponsor Type

Sponsor Type for BALSALAZIDE DISODIUM
Sponsor	Trials
Industry	10