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

April 17, 2022 updated by: Ghada Mohammed Kamal Eldin Mohammed Ali, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Drug: Budesonide MMX
Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis
ACTIVE_COMPARATOR: 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 .
Drug: Prednisolone
It is a corticosteroid used as a standard therapy for management of ulcerative colitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of the efficacy of both budesonide MMX and prednisolone.
Time Frame: 8 weeks

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.
Time Frame: 8 weeks

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.
Time Frame: 8 weeks
-to compare the : endoscopic out come using mayo scoring system.
8 weeks
comparison of the efficacy of both budesonide MMX and prednisolone.
Time Frame: 8 weeks
to compare the histological remission
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
Time Frame: 12 months
to detect the side effects reported by the patients in each group and compare them to each other.
12 months
Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2022

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

June 1, 2024

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

April 17, 2022

First Posted (ACTUAL)

April 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 17, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Budesonide in UC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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