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Clinical trials for Proctitis

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
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    • 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   44336   clinical trials with a EudraCT protocol, of which   7366   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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    36 result(s) found for: Proctitis. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2006-000329-78 Sponsor Protocol Number: PMF603-PA1/06 Start Date*: 2006-06-14
    Sponsor Name:PROMEFARM
    Full Title: Naburen enema for prevention of radiation proctitis. A multicentre randomised placebo-controlled dose-finding phase II study to evaluate efficacy, tolerability, acceptability and compliance with en...
    Medical condition: Radiation Proctitis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10036774 Proctitis LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005697-46 Sponsor Protocol Number: RCT 06 Start Date*: 2007-02-12
    Sponsor Name:SOFAR SPA
    Full Title: Prevention of actinic proctitis by beclomethasone dipropionate. A prospectic,randomised, double blind placebo controlled pilot study
    Medical condition: actinic proctitis
    Disease: Version SOC Term Classification Code Term Level
    6.1 10036783 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001921-15 Sponsor Protocol Number: BUS-4/UCA Start Date*: 2017-03-09
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomised, double-blind, double-dummy, multicentre study to compare the efficacy and safety of once daily novel 4 mg budesonide suppository versus once daily 2 mg budesonide foam in patients with ...
    Medical condition: Acute Ulcerative Proctitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045368 Ulcerative proctitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LV (Completed) HU (Completed) SK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2007-002082-13 Sponsor Protocol Number: BUF-17/RAP Start Date*: 2008-07-09
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomised, double-blind, placebo-controlled, multicentre, comparative phase II pilot study on the efficacy and tolerability of an 8-week rectal treatment with 2 mg budesonide or placebo for the pr...
    Medical condition: prevention of acute radiation proctitis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10037766 Radiation proctitis LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000319-18 Sponsor Protocol Number: FW-UC-001 Start Date*: 2018-02-07
    Sponsor Name:FIRST WAVE BIOPHARMA INCORPORATION
    Full Title: A phase I/IIa, open-label, three-stage, study to investigate the safety, the efficacy and the pharmacokinetics of Niclosamide enemas in subjects with active Ulcerative Proctitis or Ulcerative Proct...
    Medical condition: Active ulcerative proctitis or ulcerative procto-sigmoiditis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036783 Proctitis ulcerative PT
    20.0 10017947 - Gastrointestinal disorders 10036789 Proctosigmoiditis LLT
    20.1 10017947 - Gastrointestinal disorders 10045362 Ulcerative (chronic) proctosigmoiditis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) DE (Prematurely Ended) AT (Completed)
    Trial results: (No results available)
    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: 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: 2019-001916-44 Sponsor Protocol Number: MiFlaPRO_2019 Start Date*: 2020-01-28
    Sponsor Name:Medical University Innsbruck, Department of Visceral, Transplant und Thoracic Surgery
    Full Title: A multicenter, randomized, double blind placebo controlled trial of Micronized purified Flavonoid- Fraction (MPFF) in the management of radiation proctitis
    Medical condition: Patients with radiation proctitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001259-11 Sponsor Protocol Number: 80-83600-98-10006 Start Date*: 2013-12-19
    Sponsor Name:Zon MW
    Full Title: Tacrolimus suppositories versus beclomethason suppositories for the treatment of proctitis refractory to local 5-ASA.
    Medical condition: Refractory and/of recurrent ulcerative proctitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-002036-25 Sponsor Protocol Number: version1 Start Date*: 2006-11-09
    Sponsor Name:University Hospitals of Leicester NHS Trust
    Full Title: Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis
    Medical condition: Ulcerative Colitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003153-15 Sponsor Protocol Number: GS-US-419-4016 Start Date*: 2017-08-01
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn’s Disease
    Medical condition: Perianal Fistulizing Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10075465 Fistulizing Crohn's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) CZ (Completed) DE (Completed) PL (Completed) ES (Completed) AT (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003524-75 Sponsor Protocol Number: LUMC-MDLZ-MSCIBD03 Start Date*: 2018-03-27
    Sponsor Name:Leiden University Medical Center
    Full Title: Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells for the Treatment of Refractory Proctitis in 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: NL (Ongoing)
    Trial results: (No results available)
    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: 2006-005377-22 Sponsor Protocol Number: BUC-57/UCA Start Date*: 2007-10-23
    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 9 mg budesonide or 3 g mesalazine in pat...
    Medical condition: Treatment of ulcerative colitis
    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) LT (Prematurely Ended) LV (Prematurely Ended) CZ (Prematurely Ended) ES (Prematurely Ended) PL (Completed) SK (Prematurely Ended)
    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
    EudraCT Number: 2006-003340-33 Sponsor Protocol Number: Antrorect01-06 Start Date*: 2006-12-21
    Sponsor Name:BRACCO
    Full Title: Preliminary evaluation of efficacy and tolerability of the association mesalazine 1g nifedipine 10mg in the treatment of tenesmus in patients suffering of distal ulcerative cholitis. Open study, ...
    Medical condition: Tenesmus in patients with distal ulcerative cholitis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10038063 Rectal haemorrhage LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003616-10 Sponsor Protocol Number: ITM202101 Start Date*: 2021-11-04
    Sponsor Name:Institute of Tropical Medicine
    Full Title: An open label randomized controlled trial comparing the effect of ceftriaxone plus azithromycin versus ceftriaxone for the treatment of Neisseria gonorrhoeae on the resistome
    Medical condition: Neisseria gonorrhoeae (Ng)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004862 10051970 Neisseria gonorrhoeae infection LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003490-10 Sponsor Protocol Number: GETAID-2018-01 Start Date*: 2019-09-30
    Sponsor Name:GETAID
    Full Title: An open-label randomized trial COmparing staNdard of care versus Treat to target with telemonitoRing and patient education in patients with ulcerative cOlitis initiating adalimumab : The CONTROL tr...
    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: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000572-28 Sponsor Protocol Number: SHP647-302 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 Ulcerative Colitis (FIGARO UC 302)
    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: IE (Completed) HU (Completed) SK (Completed) BG (Completed) GR (Completed) BE (Completed) ES (Prematurely Ended) PT (Completed) FR (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
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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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