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Clinical trials for Mesalazine

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    100 result(s) found for: Mesalazine. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2010-018557-35 Sponsor Protocol Number: 2010-3 Start Date*: 2010-11-08
    Sponsor Name:University Medical Center Groningen
    Full Title: Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment.
    Medical condition: Ulcerative colitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-006198-26 Sponsor Protocol Number: SAG-44/DIV Start Date*: 2007-07-23
    Sponsor Name:University of Nottingham
    Full Title: Mechanistic randomised contorlled trial of Mesalazine in symptomatic diverticular disease
    Medical condition: Symptomatic diverticular disease defines as patients with recurrent abdominal pain on more then 3 days per month with proven diverticula.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-001218-15 Sponsor Protocol Number: SAG-27/UCR Start Date*: 2005-04-04
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granule...
    Medical condition: Maintenance therapy of ulcerative colitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LT (Completed) SK (Completed) HU (Completed) EE (Completed) LV (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2004-005018-35 Sponsor Protocol Number: SAS-6/UCA Start Date*: 2005-10-31
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomized, single-blind, multicentre study to compare the efficacy and safety of once daily 1 g mesalazine suppositories versus three times daily 0.5 g mesalazine suppositories in patients with ac...
    Medical condition: acute ulcerative proctitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003728-19 Sponsor Protocol Number: DDD19IBDMES2 Start Date*: 2021-01-27
    Sponsor Name:KU Leuven
    Full Title: Intestinal disposition of mesalazine in healthy volunteers
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2005-002784-91 Sponsor Protocol Number: HAW0501 Start Date*: 2006-02-06
    Sponsor Name:Cardiff and Vale NHS Trust
    Full Title: A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Dai...
    Medical condition: Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody d...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-001216-31 Sponsor Protocol Number: SAG-26/UCA Start Date*: 2005-05-30
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in...
    Medical condition: Therapy of active ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    7.1 10058816 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LT (Completed) SK (Completed) HU (Completed) LV (Completed) CZ (Completed) EE (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2019-001009-26 Sponsor Protocol Number: DDD19GISAM Start Date*: 2019-09-10
    Sponsor Name:KU Leuven - Drug Delivery and Disposition
    Full Title: Gastrointestinal behaviour of mesalazine in healthy volunteers
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-001830-32 Sponsor Protocol Number: SAT-25/UCA Start Date*: 2013-01-15
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine ver...
    Medical condition: Active ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) LV (Completed) LT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-003362-41 Sponsor Protocol Number: BUS-2/UCA Start Date*: 2013-07-24
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomized, double-blind, multicentre study to compare the efficacy and safety of two different dosages of a novel budesonide suppository versus a mesalazine suppository versus a combination therap...
    Medical condition: Acute ulcerative proctitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-002802-31 Sponsor Protocol Number: PENT-IBD-CH CZ Start Date*: 2005-01-25
    Sponsor Name:Ferring-Leciva, a.s.
    Full Title: Multicentre, Controlled, Randomised, Open, Cross-over Study Comparing the Acceptability of Pentasa® Sachets versus Pentasa® tbl. 500mg in Children with Crohn´s Disease
    Medical condition: children patients with the Crohn s disease in any stage (where mesalazine treatment is appropriate)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2012-002024-32 Sponsor Protocol Number: Mesapol Start Date*: 2012-09-21
    Sponsor Name:Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und Hepatologie
    Full Title: Mesapol: The effect of mesalazine on molecular pathways of cell adhesion in patients with colon polyps
    Medical condition: Colon polyps
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10066021 Acquired colon polyposis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-011220-62 Sponsor Protocol Number: 80-82310-98-09098 Start Date*: 2009-10-26
    Sponsor Name:University Medical Center Utrecht
    Full Title: A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study
    Medical condition: 1. Patients with a diagnosis of quiscent (CDAI < 150) Crohn's Disease (CD) according to established clinical, endoscopic, radiological and histological criteria. 2. Patients will be aged 18 years ...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011401 Crohn's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-003334-16 Sponsor Protocol Number: BUS-5/UCA Start Date*: 2020-06-26
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine mo...
    Medical condition: acute ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10066678 Acute ulcerative colitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) BG (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2004-004077-29 Sponsor Protocol Number: 2004112 Start Date*: 2005-02-04
    Sponsor Name:Procter & Gamble Pharmaceuticals
    Full Title: A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day pl...
    Medical condition: Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody d...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LT (Completed) SK (Completed) CZ (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-004083-77 Sponsor Protocol Number: NO 002 CS 001 Start Date*: 2004-12-13
    Sponsor Name:Disphar International B.V.
    Full Title: A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate...
    Medical condition: Moderate active Crohn disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) SK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001815-29 Sponsor Protocol Number: MDL_2011_36557 Start Date*: 2011-11-11
    Sponsor Name:UMC Utrecht
    Full Title: Chemopreventive effects of mesalazine in patients at high risk of recurrent (nonfamilial) colorectal adenomas
    Medical condition: sporadic colorectal adenomas
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10069428 Colon adenomatous polyp LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-015158-39 Sponsor Protocol Number: SAG-51/DIV Start Date*: 2010-05-06
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, dose-response, randomised, placebo-controlled, parallel group, multicentre phase III clinical study on the efficacy and tolerability of mesalazine granules vs. placebo for the prevent...
    Medical condition: Diverticulitis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10013538 Diverticulitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) FI (Prematurely Ended) BE (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003076-13 Sponsor Protocol Number: UIC1212 Start Date*: 2019-10-14
    Sponsor Name:Instituto Português de Oncologia de Lisboa Francisco Gentil
    Full Title: Effect of topical mesalazine on the formation of adenomas in rectal stumps or ileal pouches of familial adenomatous polyposis or MUTYH associated polyposis patients after colectomy
    Medical condition: Familial adenomatous polyposis(FAP) and MUTYH-associated polyposis (MAP)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056981 Adenomatous polyposis coli PT
    20.1 10010331 - Congenital, familial and genetic disorders 10059327 Familial adenomatous polyposis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-001683-10 Sponsor Protocol Number: BIRD2022001 Start Date*: 2022-11-28
    Sponsor Name:BIRD vzw (Belgian IBD Research and Development)
    Full Title: ChAracterizing the Remission status in patients with Ulcerative Colitis treated by 5-ASA
    Medical condition: Ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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