Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Covington
AstraZeneca
Deloitte
Cipla
Moodys
Express Scripts
Baxter
Harvard Business School

Generated: January 19, 2019

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR LIALDA

« Back to Dashboard

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.
Trial ID Title Status Sponsor Phase Summary

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Clinical Trial Conditions for Lialda

Condition Name

Condition Name for Lialda
Intervention Trials
Healthy 4
Ulcerative Colitis 3
Diverticulitis 1
Irritable Bowel Syndrome 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Lialda
Intervention Trials
Ulcer 3
Colitis, Ulcerative 3
Colitis 3
Syndrome 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Lialda
Location Trials
Kansas 5
Florida 5
Maryland 4
Georgia 3
Texas 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Lialda
Clinical Trial Phase Trials
Completed 7
Recruiting 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Lialda

Sponsor Name

Sponsor Name for Lialda
Sponsor Trials
Shire 7
James Lewis 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Lialda
Sponsor Trials
Industry 9
Other 2
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Mallinckrodt
Queensland Health
Harvard Business School
McKinsey
Healthtrust
Deloitte
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.