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Generated: September 20, 2018

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CLINICAL TRIALS PROFILE FOR LIALDA

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Clinical Trials for Lialda

Trial ID Title Status Sponsor Phase Summary
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 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 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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Lialda

Condition Name

Condition Name for Lialda
Intervention Trials
Healthy 4
Ulcerative Colitis 3
Irritable Bowel Syndrome 1
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Condition MeSH

Condition MeSH for Lialda
Intervention Trials
Colitis, Ulcerative 3
Colitis 3
Ulcer 3
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Clinical Trial Locations for Lialda

Trials by Country

Trials by Country for Lialda
Location Trials
United States 69
Brazil 7
Netherlands 5
Canada 5
Hungary 4
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Trials by US State

Trials by US State for Lialda
Location Trials
Kansas 5
Florida 5
Maryland 4
New Jersey 3
Minnesota 3
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Clinical Trial Progress for Lialda

Clinical Trial Phase

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

Clinical Trial Status for Lialda
Clinical Trial Phase Trials
Completed 7
Recruiting 2
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Clinical Trial Sponsors for Lialda

Sponsor Name

Sponsor Name for Lialda
Sponsor Trials
Shire 7
University of Utah 1
Shire Human Genetic Therapies, Inc. 1
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Sponsor Type

Sponsor Type for Lialda
Sponsor Trials
Industry 9
Other 2
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Queensland Health
Accenture
Teva
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Boehringer Ingelheim
Colorcon
Citi
Chubb

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