Back to resultsBudesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
Primary Purpose
Ulcerative Colitis Chronic
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Budesonide MMX
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis Chronic focused on measuring ulcerative colitis., Budesonide, prednisolone
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Budesonide MMX
prednisolone
Arm Description
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.
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 .
Outcomes
Primary Outcome Measures
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.
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
comparison of the efficacy of both budesonide MMX and prednisolone.
-to compare the : endoscopic out come using mayo scoring system.
comparison of the efficacy of both budesonide MMX and prednisolone.
to compare the histological remission
Secondary Outcome Measures
incidence of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
to detect the side effects reported by the patients in each group and compare them to each other.
Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05341401
Brief Title
Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
Official Title
Budesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis Chronic
Keywords
ulcerative colitis., Budesonide, prednisolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Budesonide MMX
Arm Type
Active Comparator
Arm Description
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.
Arm Title
prednisolone
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
Budesonide MMX
Intervention Description
Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
It is a corticosteroid used as a standard therapy for management of ulcerative colitis
Primary Outcome Measure Information:
Title
comparison of the efficacy of both budesonide MMX and prednisolone.
Description
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.
Time Frame
8 weeks
Title
comparison of the efficacy of both budesonide MMX and prednisolone.
Description
To compare:
- laboratory out come ( CBC,CRP and fecal calprotectin) will be done at 0,4 and 8 weeks of treatment initiation
Time Frame
8 weeks
Title
comparison of the efficacy of both budesonide MMX and prednisolone.
Description
-to compare the : endoscopic out come using mayo scoring system.
Time Frame
8 weeks
Title
comparison of the efficacy of both budesonide MMX and prednisolone.
Description
to compare the histological remission
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
incidence of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
Description
to detect the side effects reported by the patients in each group and compare them to each other.
Time Frame
12 months
Title
Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghada M.Kamal Ali, PHD
Phone
01008800296
Email
Ghada.Elefaai@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
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