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Clinical trials for Inflammatory bowel disease

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   44339   clinical trials with a EudraCT protocol, of which   7369   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
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    Study title: Sonographic evaluation of inflammatory bowel disease: a prospective, blinded, comparative study. Bremner AR. And al; Pediatric Radiology. 36(9):947-53, 2006 Sep.Sonographic evaluation of inflammatory bowel disease: a prospective, blinded, comparative study. Bremner AR. And al; Pediatric Radiology. 36(9):947-53, 2006 Sep.
    Active substance: BARIUM SULPHATE
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    Document reference: 22200
    Study title: Technetium-99m-HMPAO labelled leucocytes in the detection and monitoring of inflammatory bowel disease in children. Jewell FM. And al; British Journal of Radiology. 69(822):508-14, 1996 Jun.Technetium-99m-HMPAO labelled leucocytes in the detection and monitoring of inflammatory bowel disease in children. Jewell FM. And al; British Journal of Radiology. 69(822):508-14, 1996 Jun.
    Active substance: BARIUM SULPHATE
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    Document reference: 22203
    Study title: 99mTc-stannous colloid white cell scintigraphy in childhood inflammatory bowel disease. Peacock K. And al; Journal of Nuclear Medicine. 45(2):261-5, 2004 Feb.99mTc-stannous colloid white cell scintigraphy in childhood inflammatory bowel disease. Peacock K. And al; Journal of Nuclear Medicine. 45(2):261-5, 2004 Feb.
    Active substance: BARIUM SULPHATE
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    Document reference: 22142
    Study title: Investigating inflammatory bowel disease--white cell scanning, radiology, and colonoscopy. Jobling JC. And al; Archives of Disease in Childhood. 74(1):22-6, 1996 Jan Investigating inflammatory bowel disease--white cell scanning, radiology, and colonoscopy. Jobling JC. And al; Archives of Disease in Childhood. 74(1):22-6, 1996 Jan
    Active substance: BARIUM SULPHATE
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    Document reference: 22129
    Study title: Development, Implementation, and Assessment of a Psychological Treatment Plan for Children and Adolescents with Inflammatory Bowel Disease (IBD)
    Active substance: BUDESONIDE
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    Document reference: 22915
    Study title: 5-aminosalicylate therapy is associated with higher 6-thioguanine levels in adults and children with inflammatory bowel disease in remission on 6-mercaptopurine or azathioprine.Hande S, Wilson-Rich N, Bousvaros A, Zholudev A, Maurer R, Banks P, Makrauer F, Reddy S, Burakoff R, Friedman S. Inflamm Bowel Dis. 2006 Apr;12(4):251-7.
    Active substance: Azathioprine
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    Document reference: 49271
    Study title: The Epidemiology of Pediatric Inflammatory Bowel Disease in the West Region of North America
    Active substance: BUDESONIDE
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    Document reference: 22917
    Study title: Mamula, P. et al. Total Dose Intravenous Infusion of Iron Dextran for Iron-Deficiency Anemia in Children With Inflammatory Bowel Disease, Journal of Pediatric Gastroenterology and Nutrition (2002) 34:286-290.
    Active substance: FERRIC OXIDE DEXTRAN COMPLEX
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    Document reference: 27195
    Study title: Peck, S.N. et al. Safety and efficacy of iron dextran infusions in children with inflammatory bowel disease and iron deficiency anemia, Journal of Pediatric Gastroenterology and Nutrition (1998) 27: 487.
    Active substance: FERRIC OXIDE DEXTRAN COMPLEX
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    Document reference: 27196
    Study title: Kiron M. "Sulfasalazine Therapy in Inflammatory Bowel Disease" Gastroenterology Clinics of North Ameica - Vol. 18, No.1, March 1989 Kiron M. "Sulfasalazine Therapy in Inflammatory Bowel Disease" Gastroenterology Clinics of North Ameica - Vol. 18, No.1, March 1989
    Active substance: SULFASALAZINE
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    Document reference: 42876
    Study title: Pediatr Res. 2007 Feb;61(2):209-14. Cytogenetic damage in blood lymphocytes and exfoliated epithelial cells of children with inflammatory bowel disease. Holland N, Harmatz P, Golden D, Hubbard A, Wu YY, Bae J, Chen C, Huen K, Heyman MB.
    Active substance: FOLIC ACID
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    Document reference: 28463
    Study title: A Phase 1, Open-label Study Evaluating the Safety and Pharmacokinetics of a Single Intravenous Infusion of a Chimeric Monoclonal Antibody to Human TNFα (Infliximab) in Pediatric Inflammatory Bowel Disease Subjects Receiving Maintenance Treatment with Infliximab
    Active substance: Infliximab
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    Document reference: 47439
    Study title: Safety of Picolax in inflammatory bowel disease.Evans M, Walker-Smith J, Williams Ch., 1989, BMJ 1989; 299: 1101 – 1102
    Active substance: SODIUM PICOPSULPHATE
    Study summary document link (including results): 20140709_Art 45 Studies.xlsx
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    Document reference: 48900
    Study title: Adverse events leading to modification of therapy in a large cohort of patients with inflammatory bowel disease.Hindorf U, Lindqvist M, Hildebrand H, Fagerberg U, Almer S. Aliment Pharmacol Ther. 2006 Jul 15;24(2):331-42.
    Active substance: Azathioprine
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    Document reference: 49272
    Study title: Combined use of cyclosporine and azathioprine or 6-mercaptopurine in pediatric inflammatory bowel disease.Ramakrishna J1, Langhans N, Calenda K, Grand RJ, Verhave M. J Pediatr Gastroenterol Nutr. 1996 Apr;22(3):296-302.
    Active substance: Azathioprine
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    Document reference: 49218
    Study title: Charron et al. Temporal correlation of the erythrocyte sedimentation rate with Tc-99m WBC uptake on children with inflammatory bowel diseasesClin Nucl Med. 2003 Nov; 28(11):905-7. charron m 2003
    Active substance: CERETEC
    Study summary document link (including results): 2011-09 GE cer-ces response List of published articles.doc
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    Document reference: 48622
    Study title: Low bone mineral density in children and adolescents with inflammatory bowel disease: a population-based study from Western Sweden.Schmidt S, Mellström D, Norjavaara E, Sundh SV, Saalman R. Inflamm Bowel Dis. 2009 Dec;15(12):1844-50
    Active substance: Azathioprine
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    Document reference: 49290
    Study title: Monitoring 6-thioguanine nucleotide concentrations in Japanese children and adolescents with inflammatory bowel disease.Ohtsuka Y, Arai K, Aoyagi Y, Fujii T, Yamakawa Y, Ohtani K, Ikuse T, Baba Y, Inage E, Kudo T, Suzuki R, Nagata S, Shimizu T. J Gastroenterol Hepatol. 2010 Oct;25(10):1626-30
    Active substance: Azathioprine
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    Document reference: 49294
    Study title: Monitoring azathioprine metabolite levels and thiopurine methyl transferase (TPMT) activity in children with inflammatory bowel disease.Paerregaard A, Schmiegelow K. Scand J Gastroenterol. 2002 Mar;37(3):371-2.
    Active substance: Azathioprine
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    Document reference: 49252
    Study title: Normal thiopurine methyltransferase levels do not eliminate 6-mercaptopurine or azathioprine toxicity in children with inflammatory bowel disease.Kader HA, Wenner WJ Jr, Telega GW, Maller ES, Baldassano RN. J Clin Gastroenterol. 2000 Jun;30(4):409-13.
    Active substance: Azathioprine
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    Document reference: 49233
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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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