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Clinical trials for Balsalazide

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   43893   clinical trials with a EudraCT protocol, of which   7300   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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    20 result(s) found for: Balsalazide. Displaying page 1 of 1.
    EudraCT Number: 2005-000695-40 Sponsor Protocol Number: Final Version 2, 7 June 2005 Start Date*: 2005-09-27
    Sponsor Name:University of Nottingham
    Full Title: A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6−mercaptopurine) and an aminosalicylate
    Medical condition: The medical condition is Ulcerative Colitis.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    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: 2015-000319-41 Sponsor Protocol Number: RPC01-3101 Start Date*: 2015-09-18
    Sponsor Name:Celgene International II Sàrl (CIS II)
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis
    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) SK (Completed) HU (Completed) CZ (Completed) NL (Completed) GB (Completed) BE (Completed) BG (Completed) PL (Completed) HR (Completed) LV (Completed) AT (Completed) GR (Completed) ES (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004293-33 Sponsor Protocol Number: RPC01-3202 Start Date*: 2018-03-06
    Sponsor Name:Celgene International II Sàrl
    Full Title: Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease
    Medical condition: Moderately to Severely Active Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) LT (Completed) DE (Completed) FR (Completed) SI (Completed) AT (Completed) BG (Completed) GR (Completed) ES (Ongoing) SE (Completed) NL (Completed) PL (Completed) PT (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004292-31 Sponsor Protocol Number: RPC01-3201 Start Date*: 2018-05-21
    Sponsor Name:Celgene International II Sàrl
    Full Title: Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease
    Medical condition: Moderately to Severely Active Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) CZ (Completed) DE (Completed) BG (Ongoing) ES (Ongoing) NO (Ongoing) BE (Completed) DK (Completed) PL (Ongoing) IE (Completed) GB (GB - no longer in EU/EEA) HR (Ongoing) FR (Completed) IT (Ongoing) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000642-62 Sponsor Protocol Number: M14-675 Start Date*: 2019-06-13
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulc...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10009900 Colitis ulcerative PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) LV (Completed) PT (Completed) FI (Completed) DE (Completed) GR (Completed) SE (Completed) GB (GB - no longer in EU/EEA) AT (Completed) CZ (Completed) LT (Completed) IE (Completed) HU (Completed) ES (Completed) SK (Completed) PL (Completed) FR (Completed) HR (Completed) NO (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2018-004694-27 Sponsor Protocol Number: IM011024 Start Date*: 2019-07-23
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis
    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: GB (GB - no longer in EU/EEA) HU (Completed) PL (Completed) DE (Completed) BE (Completed) CZ (Completed) FR (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2011-004765-32 Sponsor Protocol Number: ST261-DM-11-005 Start Date*: 2012-01-10
    Sponsor Name:Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
    Full Title: Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST261) Modifi...
    Medical condition: Mild ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10066678 Acute ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) SK (Completed) CZ (Prematurely Ended) NL (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000518-31 Sponsor Protocol Number: LYC-30937-2001 Start Date*: 2016-08-16
    Sponsor Name:Lycera Corp.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) HU (Completed) PL (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2009-013680-19 Sponsor Protocol Number: 541/09 Start Date*: 2009-12-18
    Sponsor Name:POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    Full Title: Phase II, Open, Monocenter Study to investigate the efficacy of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Inflammatory Bowel Disease (IBD) under Oral Stable Trea...
    Medical condition: IBD
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011401 PT
    9.1 10045282 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004583-56 Sponsor Protocol Number: MK8259-032 Start Date*: 2014-01-28
    Sponsor Name:MSD
    Full Title: Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis
    Medical condition: Ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-004770-28 Sponsor Protocol Number: ST261-DM-11-006 Start Date*: 2012-02-28
    Sponsor Name:Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
    Full Title: Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tab...
    Medical condition: Mild ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10066678 Acute ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) HU (Prematurely Ended) LV (Prematurely Ended) DE (Completed) LT (Prematurely Ended) AT (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003123-38 Sponsor Protocol Number: RPC01-202 Start Date*: 2012-12-11
    Sponsor Name:Celgene International II Sàrl (CIS II)
    Full Title: A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY...
    Medical condition: Moderately to severely active 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) HU (Completed) PL (Completed) SK (Completed) BG (Completed) GR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-002136-24 Sponsor Protocol Number: 0157 Start Date*: 2019-09-10
    Sponsor Name:Theravance Biopharma Ireland Limited
    Full Title: A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1...
    Medical condition: Moderately-to-Severely Active Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10066678 Acute ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) DE (Completed) SK (Prematurely Ended) PT (Prematurely Ended) BG (Prematurely Ended) PL (Ongoing) GR (Prematurely Ended) HU (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended) RO (Completed)
    Trial results: View results
    EudraCT Number: 2010-019970-33 Sponsor Protocol Number: CKRP203A2201 Start Date*: 2010-11-11
    Sponsor Name:Novartis Services AG
    Full Title: A multi-centre, double-blind, placebo controlled, parallel group, proof of concept study to evaluate the efficacy, safety and tolerability of KRP203 in subjects with moderately active refractory ul...
    Medical condition: Ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10045365 Ulcerative colitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) SE (Completed) BE (Completed) GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-003471-20 Sponsor Protocol Number: ST261DM01004 Start Date*: 2005-12-07
    Sponsor Name:SIGMA-TAU
    Full Title: Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patie...
    Medical condition: ULCERATIVE COLITIS
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10009900 Colitis ulcerative PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2021-005019-30 Sponsor Protocol Number: IM047-023 Start Date*: 2022-12-09
    Sponsor Name:Celgene International II Sarl
    Full Title: A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants with Moderately...
    Medical condition: Moderately to Severely Active Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) HU (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-004230-32 Sponsor Protocol Number: CMA-0402-PR-0005 Start Date*: 2007-12-07
    Sponsor Name:Chiesi Farmaceutici SpA
    Full Title: EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERA...
    Medical condition: Ulcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examination
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) ES (Completed) IT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-002025-19 Sponsor Protocol Number: RPC01-2201 Start Date*: 2015-12-30
    Sponsor Name:Celgene International II Sarl (CISII) awholly owned subsidiary of Celgene Corporation
    Full Title: A Phase 2, Multi-Center, Open-Label Induction Trial with Extension Period to Assess Endoscopic Improvement and Changes in Intestinal and Serum Biomarkers in Patients with Moderately to Severely Act...
    Medical condition: Moderately to Severely Active Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10058815 Crohn's disease acute episode LLT
    20.0 100000004856 10011402 Crohn's disease (colon) LLT
    20.0 100000004856 10011403 Crohn's disease aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002308-11 Sponsor Protocol Number: IM047-001 Start Date*: Information not available in EudraCT
    Sponsor Name:Celgene International II Sàrl
    Full Title: A phase 2/3, multicenter, randomized, double-blind study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of oral ozanimod (RPC1063) in pediatric subjects with moderately to ...
    Medical condition: Moderately to Severely Active Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) DE (Ongoing) ES (Ongoing) BE (Trial now transitioned)
    Trial results: (No results available)
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