Ulcerative Colitis ChronicPhase 2/3NCT05341401
Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
A Phase 2/3 study testing Budesonide MMX and Prednisolone in people with Ulcerative Colitis Chronic, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis Chronic
- What is being tested?
- Budesonide MMX and Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Jun 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Budesonide MMX, Prednisolone
- Keywords
- ulcerative colitis., Budesonide, prednisolone
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide MMXDrug
Budesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis
PrednisoloneDrug
It is a corticosteroid used as a standard therapy for management of ulcerative colitis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 8 weeks
comparison of the efficacy of both budesonide MMX and prednisolone.
-to compare the : endoscopic out come using mayo scoring system.
Measured: 8 weeks
comparison of the efficacy of both budesonide MMX and prednisolone.
to compare the histological remission
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 12 months
Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis ChronicStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed Kamal Eldin Mohammed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341401
- Sponsor's protocol ID
- Budesonide in UC
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Budesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05341401
- Acronym / sponsor ID
- Budesonide in UC
- Conditions
- Ulcerative Colitis Chronic
- Keywords
- ulcerative colitis., Budesonide, prednisolone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide MMX | Active comparator | Drug: Budesonide MMXthis 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. |
| prednisolone | Active comparator | Drug: Prednisolonethis 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 . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (13 listed)
- Patients < 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide MMXBudesonide MMX is a second generator corticosteroid with prolonged colonic release used for management of ulcerative colitis | Drug | Budesonide MMX |
| PrednisoloneIt is a corticosteroid used as a standard therapy for management of ulcerative colitis | Drug | prednisolone |
Primary outcome
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.
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
comparison of the efficacy of both budesonide MMX and prednisolone.
Time frame: 8 weeks
-to compare the : endoscopic out come using mayo scoring system.
comparison of the efficacy of both budesonide MMX and prednisolone.
Time frame: 8 weeks
to compare the histological remission
2 secondary outcomes
incidence of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
Time frame: 12 months
Types of side effects reported after using budesonide in mild to moderate cases of ulcerative colitis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Budesonide MMX and Prednisolone in people with Ulcerative Colitis Chronic, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada M.Kamal Ali, PHD (01008800296, Ghada.Elefaai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of the efficacy of both budesonide MMX and prednisolone. (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.