CLINICAL TRIALS PROFILE FOR LIALDA

All Clinical Trials for Lialda

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00151892 ↗	Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis	Completed	Shire	Phase 3	2005-04-08	Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.
NCT00446849 ↗	Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)	Completed	Shire	Phase 4	2007-05-01	To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.
NCT00545103 ↗	Prevention of Recurrence of Diverticulitis	Completed	Shire	Phase 3	2007-12-06	The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
NCT00652145 ↗	Dose Escalation and Remission (DEAR)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 4	2008-09-01	The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin (FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels <50µg/g stool will be observed for 48 weeks. All patients will have FCP concentration measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All patients with persistently elevated FCP will receive one or both of the following interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of Lialda. Reduction in FCP levels below 50µg/g stool 6 weeks after randomization will be the primary outcome. The proportion of patients achieving this outcome will be compared between groups using Fisher's exact test. All randomized patients as well as those who were excluded from the randomized trial because of a low FCP concentration at baseline will be followed to week 48 to determine the rate of clinical relapse.

Clinical Trial Conditions for Lialda

Condition Name

Condition Name for Lialda
Intervention	Trials
Ulcerative Colitis	6
Healthy	4
Irritable Bowel Syndrome	1
Local Drug Concentration in Gastrointestinal Tract	1

Condition MeSH

Condition MeSH for Lialda
Intervention	Trials
Colitis, Ulcerative	6
Ulcer	5
Colitis	5
Diverticulitis	1

Clinical Trial Locations for Lialda

Trials by Country

Trials by Country for Lialda
Location	Trials
United States	105
Canada	13
India	11
South Africa	9
Brazil	8

Trials by US State

Trials by US State for Lialda
Location	Trials
Florida	7
Kansas	5
Texas	5
Minnesota	5
Georgia	5

Clinical Trial Progress for Lialda

Clinical Trial Phase

Clinical Trial Phase for Lialda
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Lialda
Clinical Trial Phase	Trials
Completed	12
Terminated	1

Clinical Trial Sponsors for Lialda

Sponsor Name

Sponsor Name for Lialda
Sponsor	Trials
Shire	9
University of Utah	1
Food and Drug Administration (FDA)	1

Sponsor Type

Sponsor Type for Lialda
Sponsor	Trials
Industry	11
Other	4
U.S. Fed	1