Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525974
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-29
Brief Title:
Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation the possible efficacy and safety of febuxostat in patients with ulcerative colitis treated with mesalamine
Detailed Description:
Ulcerative colitis UC is a sub-category of inflammatory bowel diseases IBD that causes mucosal inflammation in the rectum and lower colon Although the exact pathogenesis of ulcerative colitis remains unclear potential risk factors include altered immune responses overactive immune response toward commensal microflora genetic susceptibility and environmental factors that have been considered as potential risk factors for UC
The pathogenesis of UC consists of immuno-inflammatory pathways related to the multiple components of the intestine including the epithelial barrier dysregulation of immunological responses leukocyte recruitment and genetic factors The understanding of immuno-inflammatory pathways of UC might lead to the development of a specific therapy andor a novel treatment that could be more efficient
Mesalazine also known as mesalamine or 5- amino salicylic acid 5-ASA has a well-established role in UC management It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC The mechanism of action of mesalazine is diverse It acts locally on colonic mucosa and reduces inflammation by several anti-inflammatory processes
Febuxostat FXT is a medication used in management hyperuricemia espicially in gout a condition characterized by joints pain as result of deposition of uric acid crystals due to elevated urate blood levels Its a non-purine selective xanthine oxidase inhibitor Xanthin oxidase is an enzyme that plays a main role in production of uric acid from xanthine and hypoxanthine
Furthermore there is no need for dose modification of FXT in case of renal impairment and so its great choice for many patients as it may exhibit renal protective effect and delay progression of kidney injury and according to Zhou H et al FXT appears to be well tolerated in healthy population who has normal serum uric acid levels with no serious adverse events were reported
Lately febuxostats spectrum of use has expanded over hyperuricemia management as result of its ability of amelioration oxidative stress and regulation inflammatory response due to pro -inflammatory cytokines modulation
Keyvan Amirshahrokhi and El-Mahdy NA et al inspected the potential of FXT in mitigating ulcerative colitis in mice The findings from those studies suggest that febuxostat may exert anti- inflammatory effects in the context of ulcerative colitis Febuxostats anti- inflammatory effects in ulcerative colitis may be linked to its inhibition of the nuclear factor kappa B NF-κB signaling pathway a key regulator of inflammation This inhibition can reduce the production of proinflammatory cytokines contributing to its anti-inflammatory properties
Although preclinical studies in animal models are promising translating these results into clinical applications is necessary to evaluate the safety and efficacy of FXT in managing UC in human
The pathogenesis of UC consists of immuno-inflammatory pathways related to the multiple components of the intestine including the epithelial barrier dysregulation of immunological responses leukocyte recruitment and genetic factors The understanding of immuno-inflammatory pathways of UC might lead to the development of a specific therapy andor a novel treatment that could be more efficient
Mesalazine also known as mesalamine or 5- amino salicylic acid 5-ASA has a well-established role in UC management It is the first line therapy for mild to moderate UC and it is considered the cornerstone in the management of UC The mechanism of action of mesalazine is diverse It acts locally on colonic mucosa and reduces inflammation by several anti-inflammatory processes
Febuxostat FXT is a medication used in management hyperuricemia espicially in gout a condition characterized by joints pain as result of deposition of uric acid crystals due to elevated urate blood levels Its a non-purine selective xanthine oxidase inhibitor Xanthin oxidase is an enzyme that plays a main role in production of uric acid from xanthine and hypoxanthine
Furthermore there is no need for dose modification of FXT in case of renal impairment and so its great choice for many patients as it may exhibit renal protective effect and delay progression of kidney injury and according to Zhou H et al FXT appears to be well tolerated in healthy population who has normal serum uric acid levels with no serious adverse events were reported
Lately febuxostats spectrum of use has expanded over hyperuricemia management as result of its ability of amelioration oxidative stress and regulation inflammatory response due to pro -inflammatory cytokines modulation
Keyvan Amirshahrokhi and El-Mahdy NA et al inspected the potential of FXT in mitigating ulcerative colitis in mice The findings from those studies suggest that febuxostat may exert anti- inflammatory effects in the context of ulcerative colitis Febuxostats anti- inflammatory effects in ulcerative colitis may be linked to its inhibition of the nuclear factor kappa B NF-κB signaling pathway a key regulator of inflammation This inhibition can reduce the production of proinflammatory cytokines contributing to its anti-inflammatory properties
Although preclinical studies in animal models are promising translating these results into clinical applications is necessary to evaluate the safety and efficacy of FXT in managing UC in human
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None