Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis

NCT ID: NCT05341401

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2024-06-30

Brief 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.

Detailed Description

It is a randomized clinical trial where patients with mild to moderate ulcerative colitis who failed to respond to conventional therapy with mesalazine will randomly be divided into two groups one of them will be given prednisone and the other will be given budesonide MMX.

The efficacy of Budesonide MMX and Prednisolone will be measured by the rate of clinical, laboratory, endoscopic, and histological improvement 8 weeks after randomization. Clinical assessment (the rate of bowel movements and rectal bleeding) and laboratory investigations ( complete blood count [CBC], C reactive protein[CRP], and fecal calprotectin) will be done after 4 and 8 weeks from treatment initiation. Endoscopic and histological assessments will be done at week 8.

Conditions

Ulcerative Colitis Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Budesonide MMX

this study aims to detect the safety and side effects of budesonide MMX in the management of mild to moderate cases of ulcerative colitis in comparison to prednisolone. Budesonide MMX will be given after randomization to patients with mild to moderate cases who failed to respond to mesalazine. The dose will be 9mg as a single dose given for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Budesonide MMX

Intervention Type: DRUG

Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis

prednisolone

this study aims to detect the safety and side effects of budesonide MMX in the management of mild to moderate cases of ulcerative colitis in comparison to prednisolone. prdinisolone MMX will be given after randomization to patients with mild to moderate cases who failed to respond to mesalazine. The starting dose will be 40 mg and reduced by 5 mg each weak for 8 weeks .

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

It is a corticosteroid used as a standard therapy for management of ulcerative colitis

Interventions

Budesonide MMX

Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis

Intervention Type: DRUG

Prednisolone

It is a corticosteroid used as a standard therapy for management of ulcerative colitis

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Mohammed Kamal Eldin Mohammed Ali

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ghada M.Kamal Ali, PHD

Role: CONTACT

Ghada.Elefaai@gmail.com

01008800296

Other Identifiers

Budesonide in UC

Identifier Type: -

Identifier Source: org_study_id