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

NCT05341401 | Unknown Phase 2

• 1 other identifier: Budesonide in UC
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ulcerative Colitis Chronic

Keywords

ulcerative colitis.; Budesonide; prednisolone

Outcome Measures

Primary Outcomes (4)

• comparison of the efficacy of both budesonide MMX and prednisolone.

  To compare: \- the clinical out come(by number of bowel movement, presence or absence of blood and abdominal pain) assessment will be done at 0 ,4 weeks and after 8 weeks from treatment initiation in both groups.

  8 weeks

• comparison of the efficacy of both budesonide MMX and prednisolone.

  To compare: \- laboratory out come ( CBC,CRP and fecal calprotectin) will be done at 0,4 and 8 weeks of treatment initiation

  8 weeks

• comparison of the efficacy of both budesonide MMX and prednisolone.

  -to compare the : endoscopic out come using mayo scoring system.

  8 weeks

• comparison of the efficacy of both budesonide MMX and prednisolone.

  to compare the histological remission

  8 weeks

Secondary Outcomes (2)

• incidence of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis

  12 months

• Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis

  12 months

Study Arms (2)

Budesonide MMX

ACTIVE COMPARATOR

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.

Drug: Budesonide MMX

prednisolone

ACTIVE COMPARATOR

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 .

Drug: Prednisolone

Interventions

Budesonide MMX DRUG

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

Budesonide MMX

Prednisolone DRUG

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

prednisolone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Ghada M.Kamal Ali, PHD

CONTACT

01008800296; Ghada.Elefaai@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 22, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share