Crohn's Disease Clinical Trial
— CD-AT1Verified date | November 2013 |
Source | Jinling Hospital, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
Extra iron may not be necessary in the treatment of iron deficiency anemia in Crohn's Disease;Oxidative Stress and Inflammation may be Caused by Intravenous Iron in Crohn's Disease Patients With Iron Deficiency Anemia.
Status | Completed |
Enrollment | 387 |
Est. completion date | November 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria - Males and females = 18 years old, including women who are not pregnant or lactating at the time of enrollment. - Subjects should have a CDAI score <150 at week 0 - Able to swallow tablets - Are capable of providing written informed consent and obtained at the time of enrollment - Willing to adhere to the study visit schedule and other protocol requirements. - Subjects should have the hemoglobin: male patients<130g/L,female patients<120g/L. Exclusion Criteria: - Bacterial,viral or other microbial infection(including HIV) - Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable. - Previous or current use of infliximab. - current use of prescription doses or chronic/frequent use of NSAIDs - Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted) - History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis) - History of abnormal liver function tests, including AST or ALT >1.5 times upper limit of normal, alkaline phosphatase >2 times upper limit of normal, total bilirubin >2.5 mg/dL at screening (or within the previous 6 months, if known) - History of malignancy - Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period. - Participation in other clinical trial within the past 6 months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | General Surgery Institute,Jinling Hospital | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Jinling Hospital, China | Ministry of Health, China |
China,
Bergamaschi G, Di Sabatino A, Albertini R, Ardizzone S, Biancheri P, Bonetti E, Cassinotti A, Cazzola P, Markopoulos K, Massari A, Rosti V, Porro GB, Corazza GR. Prevalence and pathogenesis of anemia in inflammatory bowel disease. Influence of anti-tumor necrosis factor-alpha treatment. Haematologica. 2010 Feb;95(2):199-205. doi: 10.3324/haematol.2009.009985. Epub 2009 Oct 8. — View Citation
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Katsanos KH, Tatsioni A, Natsi D, Sigounas D, Christodoulou DK, Tsianos EV. Recombinant human erythropoietin in patients with inflammatory bowel disease and refractory anemia: a 15-year single center experience. J Crohns Colitis. 2012 Feb;6(1):56-61. doi: 10.1016/j.crohns.2011.07.004. Epub 2011 Aug 17. — View Citation
Kulnigg S, Gasche C. Systematic review: managing anaemia in Crohn's disease. Aliment Pharmacol Ther. 2006 Dec;24(11-12):1507-23. Review. — View Citation
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Reinisch W, Staun M, Bhandari S, Muñoz M. State of the iron: how to diagnose and efficiently treat iron deficiency anemia in inflammatory bowel disease. J Crohns Colitis. 2013 Jul;7(6):429-40. doi: 10.1016/j.crohns.2012.07.031. Epub 2012 Aug 20. Review. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | haemoglobin raise to norm or not. | at 0 week, the first week, the second week, the third week, the fourth week | Yes | |
Secondary | The change of haematological inflammation marker(CRP,ESR,IL-10,IL-6,TNF-a,IL-1ß) | at 0 week, the first week, the second week, the third week, the fourth week | No | |
Secondary | The change of haematological oxidative stress indicators(SOD,GSH-px and MDA) | at 0 week, the first week, the second week, the third week, the fourth week | No | |
Secondary | The change of patients'IBDQ and CDAI. | at 0 week and the fourth week | No | |
Secondary | relapse of anaemia | 12 weeks after treatment | No |
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