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Determining the effect of Montelukast in reducing disease recurrence in patients with moderate to severe ulcerative colitis during the period of gradual reduction of glucocorticoid dose.

Protocol summary

Study aim
Determining the effect of montelukast in reducing the recurrence of ulcerative colitis during the period of corticosteroid dose tapering
Design
Triple blinded , two arm parallel group randomised clinical trial
Settings and conduct
Patients with mod-sev ulcerative colitis who have entered to clinical remission after treatment of prednisolone 1 mg per kg(40-60 mg daily) and mesalazine 4 grams daily, with a full explanation of the process Continuing the maintenance drug treatment and accepting or not accepting the standard maintenance treatment of azathiopurine will be entered into the intervention group (receiving 10 mg Montelukast tablets daily) or the control group (receiving placebo tablets) for 16 weeks.patients will be monitored every two weeks in the IBD clinic by visits, questionnaires, inflammatory tests and calculation of the Modified Mayo score.The study will be triple-blind, in which the patient, the person evaluating the effects of the intervention, and the statistician will be unaware of the assignment of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 75 years,moderate to severe ulcerative colitis,stage of clinical remission,Candidate for tapering corticosteroid dose,on high dose of corticosteroid 40-60 mg daily Exclusion criteria: age younger 18 or older 75y , any major organ disease or failure,patients receiving anti-TNF drugs or cyclosporine,patients with eosinophilic colitis , impaired level of consciousness,psychological diseases,Primary sclerosing cholangitis (PSC)
Intervention groups
Intervention group: prescribing Montelukast 10 mg tablets, Abidi Pharmaceutical Company, once daily for 16 weeks. Control group: Placebo drug administration for 16 weeks
Main outcome variables
Remaining in a state of clinical remission ؛ Clinical recurrence as having symptoms and a Mayo score greater than or equal to 3

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121212011738N3
Registration date: 2022-10-13, 1401/07/21
Registration timing: registered_while_recruiting

Last update: 2022-10-13, 1401/07/21
Update count: 0
Registration date
2022-10-13, 1401/07/21
Registrant information
Name
Kurosh Masnadi Shirazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7554
Email address
masnadik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-12, 1401/07/20
Expected recruitment end date
2023-01-10, 1401/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of Montelukast in reducing disease recurrence in patients with moderate to severe ulcerative colitis during the period of gradual reduction of glucocorticoid dose.
Public title
The effect of Montelukast in reducing disease recurrence in patients with ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with moderate to severe ulcerative colitis Age 18 to 75 years Involvement beyond the rectosigmoid Treated with a high dose of corticosteroid 40-60 mg daily In the stage of clinical remission Candidate for tapering corticosteroid dose
Exclusion criteria:
Age less than 18 Age more than 75 Severely ill patients need hospitalization and special measures Pregnant or lactating women Suffering from systemic diseases including heart, kidney, lung or liver failure Patients with impaired level of consciousness patients with Primary sclerosing cholangitis (PSC) patients with eosinophilic colitis patients with psychological diseases patients receiving anti-TNF drugs or cyclosporine
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done using Graphpad software. The randomization unit is individual. So that the graphpad software will present the letter A (for the intervention group) and the letter B for the control group for two groups of our patients. This list will be in the hands of the secretary of the department and until the end of the study, only he will know about the allocation of people. Patients will be directed to one of the two groups A or B based on the list by the secretary of the department according to their visit to the clinic. The department secretary will not be involved in other research areas.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study will be triple-blind, in which the patient, the person evaluating the effects of the intervention, and the statistician will be unaware of the assignment of the groups. For blinding, the placebo will be prepared in the same packaging as the original drug, and the letters A and B will be used by the secretary of the department for the cans of drugs and placebo. And the contents of the cans will remain secret until the end of the study and only the department secretary will know about the contents of cans A and B.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2022-09-10, 1401/06/19
Ethics committee reference number
IR.TBZMED.REC.1401.496

Health conditions studied

1

Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
Remaining in a state of clinical remission
Timepoint
Every 2 weeks from the start of tapering the dose of corticosteroids until 6 weeks after complete cessation of corticosteroids
Method of measurement
History, physical examination, questionnaire , laboratory tests(ESR,CRP,CBC, Fecal calprotectin) , modified Mayo score

2

Description
Clinical recurrence as having symptoms and a Mayo score greater than or equal to 3
Timepoint
Every 2 weeks from the start of tapering the dose of corticosteroids until 6 weeks after complete cessation of corticosteroids
Method of measurement
History, physical examination, questionnaire , laboratory tests(ESR,CRP,CBC, Fecal calprotectin) , modified Mayo score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: prescribing Montelukast 10 mg tablets, Abidi Pharmaceutical Company, once daily for 16 weeks.
Category
Treatment - Drugs

2

Description
Control group: Placebo drug administration for 16 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinics of Sheikhorrais and Emam-reza hospital
Full name of responsible person
Masnadi shirazi Kurosh
Street address
Golgasht St. , Emam-reza hospital
City
Tabriz
Province
East Azarbaijan
Postal code
3333456787
Phone
+98 41 3334 7054
Email
mndiba59@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Vice chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
۳۳۳۳۴۵۶۶۷۷
Phone
+98 41 3334 7054
Email
mndiba59@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nezamdiba Mehran
Position
Gastrointestinal fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No.41 , Gulshan Boulevard, Tejalai Square
City
Tabriz
Province
East Azarbaijan
Postal code
۳۳۳۳۶۶۴۵۵۱
Phone
+98 41 3347 8021
Email
mndiba59@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Kurosh Masnadi Shirazi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Gastrointestinal Research Center ، Emamreza hospital, Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
۳۳۳۳۴۵۶۰۶۹
Phone
+98 41 1334 7554
Fax
+98 41 1334 7554
Email
masnadik@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nezamdiba Mehran
Position
Gastrointestinal fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No.41 , Gulshan Boulevard, Tejalai Square
City
Tabriz
Province
East Azarbaijan
Postal code
۳۳۳۳۶۶۴۵۵۱
Phone
+98 41 3347 8021
Email
mndiba59@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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