drugset / Trial / NCT05986136

Dapagliflozin in Patients With Ulcerative Colitis

NCT05986136 ↗

Phase 2/3 Completed 60 enrolled Mostafa Bahaa
RandomizedParallel-groupDouble-blindTreatment

Summary

The inflammatory bowel diseases (IBD) are described as complex, recurrent inflammatory conditions which are manifested as Crohn's disease (CD) and ulcerative colitis (UC). The common symptoms of IBD include debilitating/severe diarrhea, abdominal pain, weight loss, and chronic fatigue; events that may culminate in life-threatening complications. The pathogenesis of IBD has been characterized as complex/multi-factorial that includes disruption of intestinal epithelial barrier with consequent translocation of commensal microbial products as the prime event that instigates severe immune responses and intestinal inflammation.

Timeline

Start
2023-08-20
Primary completion
2026-08-20
Completion
2026-08-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dapagliflozin Small molecule 10 mg —
Comparator Mesalamine Small molecule 1 g —