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Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis

Primary Purpose

Microscopic Colitis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Budesonide MMX®
Budesonide controlled ileal release (CR) capsules
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microscopic Colitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or non-pregnant, non-lactating females, 18-80 years old years of age Females of childbearing potential must be taking adequate contraceptive precautions (i.e., implants, injectables, hormonal intrauterine devices, combined hormonal contraceptives, having a vasectomized partner or total abstinence from heterosexual relations with no plans of becoming pregnant through insemination or in vitro fertilization) and have a negative urine pregnancy test prior to randomization. Active symptoms of MC defined by non-bloody, watery diarrhea or loose bowel movements for at least 12 weeks (for patients with newly diagnosed MC) or a history of clinical relapse for at least one week before randomization in patients with previously established MC, and with >=28 stools within 7 days preceding randomization, of which >=20 were watery/soft stools Colonoscopy or flexible sigmoidoscopy with histologically confirmed MC, defined by signs of inflammation of the lamina propria and either: lymphocytic colitis: ≥20 IELs/100 surface epithelial cells collagenous colitis: subepithelial collagen band >10 micrometers in diameter Ability of subject to participate fully in all aspects of this clinical trial Written informed consent must be obtained and documented Exclusion Criteria: Evidence of infectious diarrhea (proved by stool culture or colonic biopsy), diarrhea due to other organic diseases of the gastrointestinal tract including Crohn's disease, ulcerative colitis, ischemic colitis, Celiac disease (ruled out by either duodenal biopsy or serum antibodies), radiation colitis, or polyps >2cm, suspicion of drug-induced MC History of partial or total colonic resection Previous exposure to >7 days of any budesonide formulation for treatment of MC Unwillingness to withhold protocol-proscribed medications during the trial Received any of: aminosalicylates, corticosteroids (other than budesonide), immunosuppressants (including thiopurines and methotrexate), bismuth subsalicylate, cholestyramine, biological treatments, or antibiotics (except for up to a 7-day course for conditions unrelated to microscopic colitis) within 8 weeks of randomization Use of loperamide or diphenoxylate/atropine as an anti-diarrheal agent is not permitted during the screening period Serious underlying disease other than MC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study, including a history of: Severe anaemia (haemoglobin < 90 g/L) or leukopenia (white blood cell count < 2.5 x 109 cells/L) Known infection with hepatitis B, hepatitis C, or human immunodeficiency virus not on effective anti-viral therapy Active malignancy Cirrhosis or significant hepatic or renal insufficiency Poorly controlled type 1 or type 2 diabetes Glaucoma History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures. Pregnant or lactating women Hypersensitivity to the active ingredient of budesonide MMX® or budesonide CR and excipients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Budesonide MMX®

    Budesonide controlled ileal release (CR) capsules

    Arm Description

    Participant received 9 mg delayed and extended-release tablet, once daily, oral administration, for 8 weeks

    Participant received three 3 mg capsules, daily oral administration, for 8 weeks

    Outcomes

    Primary Outcome Measures

    Clinical remission
    Hjortswang criteria defines clinical remission as a daily average <3 loose/watery bowel movements per 24 hours in the week preceding the final assessment (loose/watery stool consistency will be measured using the Bristol Stool Chart (types 6 and 7)

    Secondary Outcome Measures

    Histologic remission
    <20 IELs/100 surface epithelial cells and subepithelial collagen band <10 micrometers in biopsy samples and a reduction in lamina propria inflammation
    Histologic response
    50% reduction in IEL count or subepithelial collagen band thickness compared to baseline and/or a reduction in lamina propria inflammation
    Clinical response
    50% reduction in average daily stool frequency for the week prior to final assessment compared to baseline
    Patient-reported symptom improvement
    Change in the European Microscopic Colitis Activity Index (E-MCAI) and its component items, including stool frequency and consistency (stools per day, solid vs. loose stools, stools of each Bristol Stool chart consistency), stools at night, feeling of a need to pass more stools shortly after a bowel movement, urgency of defecation, leakage, and abdominal pain

    Full Information

    First Posted
    June 13, 2023
    Last Updated
    June 13, 2023
    Sponsor
    University of Calgary
    Collaborators
    Ferring Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05915104
    Brief Title
    Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis
    Official Title
    Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis: A Prospective, Randomized, Active Comparator Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2026 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Calgary
    Collaborators
    Ferring Pharmaceuticals

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this research study is to compare how well two formulations of budesonide (budesonide MMX [Cortiment] and budesonide CR [Entocort]) work for treating patients with microscopic colitis.
    Detailed Description
    After being informed of the study and potential risks, patients with symptomatically active microscopic colitis who provide written informed consent will undergo a 4-week screening period to determine their eligibility for the study. At week 0, eligible patients will be randomized in a single blind manner (patients will be aware, while investigators will be blinded) in a 1:1 ratio to budesonide MMX (9mg once daily) or budesonide CR (3mg three times daily). The total treatment duration will be for 8 weeks. The primary outcome will be clinical remission, defined by the Hjortswang criteria (daily average <3 loose/watery bowel movements per 24 hours in the week preceding the final assessment (loose/watery stool consistency will be measured using the Bristol Stool Chart (types 6 and 7)).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Microscopic Colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    This phase 2a trial is a prospective, randomized, single-blinded (investigator-blinded), active comparator clinical study. Eligible participants with active Microscopic Colitis will be randomized 1:1 to receive either budesonide MMX® or budesonide CR 9 mg daily for 8 weeks.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    All qualified participants will be randomly assigned in a 1:1 ratio to receive budesonide MMX® or budesonide CR. Blocked randomization (block size of 8) will be stratified on disease subtype (collagenous colitis vs. lymphocytic colitis). Randomization will be conducted through the REDCap® clinical trials randomization module, which will generate a random, blinded allocation sequence that will be concealed to both investigators and participants. An independent pharmacist will prepare all treatment packages. Budesonide will be packaged into 4-week increments (two packages per 8-week treatment course). These treatment packages will be identical in appearance and size and labelled with a randomly generated study identification number. Investigators will not know the contents of each treatment package. At the randomization visit, eligible participants will be randomized and be given the corresponding treatment package. Participants will not be blinded to treatment.
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Budesonide MMX®
    Arm Type
    Experimental
    Arm Description
    Participant received 9 mg delayed and extended-release tablet, once daily, oral administration, for 8 weeks
    Arm Title
    Budesonide controlled ileal release (CR) capsules
    Arm Type
    Active Comparator
    Arm Description
    Participant received three 3 mg capsules, daily oral administration, for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Budesonide MMX®
    Other Intervention Name(s)
    Cortiment®
    Intervention Description
    9 mg delayed and extended-release tablet once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Budesonide controlled ileal release (CR) capsules
    Other Intervention Name(s)
    Entocort®
    Intervention Description
    three 3 mg capsules daily oral administration for 8 weeks
    Primary Outcome Measure Information:
    Title
    Clinical remission
    Description
    Hjortswang criteria defines clinical remission as a daily average <3 loose/watery bowel movements per 24 hours in the week preceding the final assessment (loose/watery stool consistency will be measured using the Bristol Stool Chart (types 6 and 7)
    Time Frame
    Week 8
    Secondary Outcome Measure Information:
    Title
    Histologic remission
    Description
    <20 IELs/100 surface epithelial cells and subepithelial collagen band <10 micrometers in biopsy samples and a reduction in lamina propria inflammation
    Time Frame
    Week 8
    Title
    Histologic response
    Description
    50% reduction in IEL count or subepithelial collagen band thickness compared to baseline and/or a reduction in lamina propria inflammation
    Time Frame
    Week 8
    Title
    Clinical response
    Description
    50% reduction in average daily stool frequency for the week prior to final assessment compared to baseline
    Time Frame
    Week 8
    Title
    Patient-reported symptom improvement
    Description
    Change in the European Microscopic Colitis Activity Index (E-MCAI) and its component items, including stool frequency and consistency (stools per day, solid vs. loose stools, stools of each Bristol Stool chart consistency), stools at night, feeling of a need to pass more stools shortly after a bowel movement, urgency of defecation, leakage, and abdominal pain
    Time Frame
    Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or non-pregnant, non-lactating females, 18-80 years old years of age Females of childbearing potential must be taking adequate contraceptive precautions (i.e., implants, injectables, hormonal intrauterine devices, combined hormonal contraceptives, having a vasectomized partner or total abstinence from heterosexual relations with no plans of becoming pregnant through insemination or in vitro fertilization) and have a negative urine pregnancy test prior to randomization. Active symptoms of MC defined by non-bloody, watery diarrhea or loose bowel movements for at least 12 weeks (for patients with newly diagnosed MC) or a history of clinical relapse for at least one week before randomization in patients with previously established MC, and with >=28 stools within 7 days preceding randomization, of which >=20 were watery/soft stools Colonoscopy or flexible sigmoidoscopy with histologically confirmed MC, defined by signs of inflammation of the lamina propria and either: lymphocytic colitis: ≥20 IELs/100 surface epithelial cells collagenous colitis: subepithelial collagen band >10 micrometers in diameter Ability of subject to participate fully in all aspects of this clinical trial Written informed consent must be obtained and documented Exclusion Criteria: Evidence of infectious diarrhea (proved by stool culture or colonic biopsy), diarrhea due to other organic diseases of the gastrointestinal tract including Crohn's disease, ulcerative colitis, ischemic colitis, Celiac disease (ruled out by either duodenal biopsy or serum antibodies), radiation colitis, or polyps >2cm, suspicion of drug-induced MC History of partial or total colonic resection Previous exposure to >7 days of any budesonide formulation for treatment of MC Unwillingness to withhold protocol-proscribed medications during the trial Received any of: aminosalicylates, corticosteroids (other than budesonide), immunosuppressants (including thiopurines and methotrexate), bismuth subsalicylate, cholestyramine, biological treatments, or antibiotics (except for up to a 7-day course for conditions unrelated to microscopic colitis) within 8 weeks of randomization Use of loperamide or diphenoxylate/atropine as an anti-diarrheal agent is not permitted during the screening period Serious underlying disease other than MC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study, including a history of: Severe anaemia (haemoglobin < 90 g/L) or leukopenia (white blood cell count < 2.5 x 109 cells/L) Known infection with hepatitis B, hepatitis C, or human immunodeficiency virus not on effective anti-viral therapy Active malignancy Cirrhosis or significant hepatic or renal insufficiency Poorly controlled type 1 or type 2 diabetes Glaucoma History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures. Pregnant or lactating women Hypersensitivity to the active ingredient of budesonide MMX® or budesonide CR and excipients
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christopher Ma, MD MPH
    Phone
    403-592-5013
    Email
    christopher.ma@ucalgary.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Katherine Buhler
    Email
    kaewert@ucalgary.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Ma, MD MPH
    Organizational Affiliation
    University of Calgary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Deidentified IPD may be shared upon completion of the study and with formal written request
    IPD Sharing Time Frame
    Data will be available and stored for 15 years after the study completion

    Learn more about this trial

    Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis

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