Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis (NCT05341401) | Clinical Trial Compass
UnknownPhase 2/3
Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
100 participantsStarted 2022-06
Plain-language summary
My study aims to directly compare the efficacy and safety of Budesonide MMX versus Prednisolone in the management of mild to moderate cases of ulcerative colitis.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* This study will include patients with confirmed mild to moderate ulcerative colitis according to the Mayo score activity index with ages ranging between 18-60 years old.
Exclusion Criteria:
* Patients \< 18 years old.
* Pregnant females.
* Patients with proven infection with any enteric pathogens (e.g., Shigella species, Clostridium species, Salmonella species, ova, parasites, Clostridium difficile toxins A or B, or HIV infection).
* Patients who received oral or rectal steroids in the last 4 weeks, immunosuppressive agents in the last 8 weeks, or anti-tumor necrosis factor agents in the last 3 months.
* Patients with severe colitis (Mayo score \>11); Patients with evidence or history of toxic megacolon.
* Severe anemia (hemoglobin \<10.5 g/dl), leucopenia, or granulocytopenia.
* Patients using any cytochrome P450 inducers or inhibitors (e.g., ketoconazole, phenytoin) or antibiotics.
* Patients with renal disease/insufficiency.
* Patients with type I diabetes.
* Patients with glaucoma.
* Patients with malignancies.
* Patients with decompensated liver cirrhosis (Child-Pugh score B and C).
* Patients with COVID 19 infection.
What they're measuring
1
comparison of the efficacy of both budesonide MMX and prednisolone.
Timeframe: 8 weeks
2
comparison of the efficacy of both budesonide MMX and prednisolone.
Timeframe: 8 weeks
3
comparison of the efficacy of both budesonide MMX and prednisolone.
Timeframe: 8 weeks
4
comparison of the efficacy of both budesonide MMX and prednisolone.