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Generated: November 15, 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.
NCT00652145 Dose Escalation and Remission (DEAR) Completed Shire 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.
NCT00652145 Dose Escalation and Remission (DEAR) Completed James Lewis 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.
NCT00751699 Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers Completed Warner Chilcott Phase 1 This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3 regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x 400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total 5-ASA percent of dose excreted (A'e [%]) over the 24-hour period on Day 7.
NCT01402947 Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine Completed Shire Phase 1 This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR administered alone & in combination with MMX Mesalazine/mesalamine.
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
Diverticulitis 1
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Condition MeSH

Condition MeSH for Lialda
Intervention Trials
Ulcer 3
Colitis, Ulcerative 3
Colitis 3
Irritable Bowel Syndrome 1
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Clinical Trial Locations for Lialda

Trials by Country

Trials by Country for Lialda
Location Trials
United States 69
Brazil 7
Canada 5
Netherlands 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
Warner Chilcott 1
James Lewis 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
UBS
Boehringer Ingelheim
Colorcon
Citi
Chubb

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