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Clinical trials for Mesalamine

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44347   clinical trials with a EudraCT protocol, of which   7375   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    58 result(s) found for: Mesalamine. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2011-000164-10 Sponsor Protocol Number: SPD476-112 Start Date*: 2013-01-04
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2009-017044-13 Sponsor Protocol Number: SPD476-409 Start Date*: 2010-06-30
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) IE (Completed) HU (Completed) BE (Completed) CZ (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-002558-11 Sponsor Protocol Number: 000175 Start Date*: 2015-12-07
    Sponsor Name:Ferring International PharmaScience Center U.S., Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscop...
    Medical condition: Ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004856 10058816 Colitis ulcerative acute episode LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) LV (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2007-004732-23 Sponsor Protocol Number: EMET 001 Start Date*: 2007-10-22
    Sponsor Name:EMET Pharmaceuticals LLC
    Full Title: A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The ...
    Medical condition: Mild to moderately active ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009900 Colitis ulcerative LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LV (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002557-35 Sponsor Protocol Number: 000174 Start Date*: 2015-12-07
    Sponsor Name:Ferring International PharmaScience Center U.S., Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endosc...
    Medical condition: Active, mild to moderate ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004856 10058816 Colitis ulcerative acute episode LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) LV (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2006-001310-32 Sponsor Protocol Number: 2006444 Start Date*: 2006-06-16
    Sponsor Name:Procter & Gamble Technical Centres Limited
    Full Title: A double-blind, randomized, 6-week, parallel-group clinical trial to assess the safety and efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet)...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10009900
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LT (Completed) CZ (Completed) HU (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2007-005166-12 Sponsor Protocol Number: HMPL-004-US-02 Start Date*: 2008-07-29
    Sponsor Name:Hutchison MediPharma Enterprises Limited
    Full Title: A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine
    Medical condition: active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066678 Acute ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-002542-38 Sponsor Protocol Number: CAEB071A2210 Start Date*: 2007-11-28
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis.
    Medical condition: Ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-003702-27 Sponsor Protocol Number: PCG-2/UCA Start Date*: 2014-05-08
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granu...
    Medical condition: Acute Ulcerative Colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Prematurely Ended) AT (Prematurely Ended) CZ (Prematurely Ended) SK (Prematurely Ended) HU (Completed) LT (Prematurely Ended) LV (Prematurely Ended) NL (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001744-65 Sponsor Protocol Number: SPD476-319 Start Date*: 2014-10-22
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acu...
    Medical condition: Mild to Moderate Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) SK (Completed) NL (Prematurely Ended) PL (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001205-84 Sponsor Protocol Number: PCG-4/UCR Start Date*: 2015-01-13
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus plac...
    Medical condition: Maintenance of remission in ulcerative colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) LT (Completed) LV (Completed) SK (Completed) BE (Completed) AT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2019-003011-55 Sponsor Protocol Number: MesaCAPP Start Date*: 2020-07-23
    Sponsor Name:Karolinska Institute
    Full Title: Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
    Medical condition: Lynch Syndrome, which is increasing the risk of developing colorectal cancer.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10051981 Lynch syndrome LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000659-11 Sponsor Protocol Number: GLPG3970-CL-210 Start Date*: 2020-09-10
    Sponsor Name:Galapagos NV
    Full Title: A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-017839-18 Sponsor Protocol Number: PG09-PUR 0210-002 Start Date*: 2010-05-14
    Sponsor Name:PurGenesis Techonologies Inc.
    Full Title: A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODER...
    Medical condition: Active mild-to-moderate distal ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    13.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-003548-35 Sponsor Protocol Number: MesaCAPP Start Date*: 2017-03-10
    Sponsor Name:Medical University of Vienna
    Full Title: Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome
    Medical condition: Colorectal Cancer Prevention in Lynch syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10051981 Lynch syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) NL (Prematurely Ended) SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-002100-26 Sponsor Protocol Number: FE 999907 CS05 Start Date*: 2009-01-28
    Sponsor Name:Ferring Pharmaceuticals A/S
    Full Title: PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo
    Medical condition: Active mild to moderate crohn's disease.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011401 Crohn's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) SE (Prematurely Ended) DK (Prematurely Ended) GB (Prematurely Ended) FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000575-88 Sponsor Protocol Number: SHP647-305 Start Date*: 2019-02-28
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 305)
    Medical condition: Crohn's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) AT (Completed) LT (Completed) CZ (Prematurely Ended) DE (Completed) PL (Completed) HR (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2013-002116-27 Sponsor Protocol Number: HMPL-004-03 Start Date*: 2013-10-28
    Sponsor Name:Nutrition Science Partners Limited
    Full Title: A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)
    Medical condition: Ulcerative Colitis (UC)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Prematurely Ended) HU (Prematurely Ended) LT (Prematurely Ended) CZ (Prematurely Ended) BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-000576-29 Sponsor Protocol Number: SHP647-306 Start Date*: Information not available in EudraCT
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306)
    Medical condition: Crohn’s disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10011402 Crohn's disease (colon) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) BE (Completed) HU (Completed) SK (Completed) ES (Prematurely Ended) PT (Completed) EE (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2017-000599-27 Sponsor Protocol Number: SHP647-301 Start Date*: 2018-04-10
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)
    Medical condition: Ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) LT (Completed) CZ (Completed) NL (Completed) PL (Completed) GB (GB - no longer in EU/EEA) HR (Completed) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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