Comparison of the effects of omeprazole and placebo in the prevention of acute gastrointestinal events in hospitalized patients with multiple sclerosis receiving corticosteroid pulse: A Prospective randomized double-blind placebo control clinical trial
Comparison of the effects of omeprazole and placebo in patients with MS receiving corticosteroids pulse in the prevention of acute gastrointestinal complications
Design
A Prospective randomized double-blind placebo control clinical trial
Settings and conduct
In this prospective clinical trial, patients with MS admitted to Sina Hospital who are candidates for corticosteroid pulse are randomly assigned to one of two groups of omeprazole 20 mg daily fasting capsules or placebo after obtaining informed consent.
During this study, in case of any of the patients with any dyspepsia, famotidine tablets will be used as PRN with a maximum dose of 40 mg per day. The amount and frequency of famotidine use in both groups will be recorded. And is compared.
For all patients, demographic information and underlying diseases and medications are recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients with recurrent types of MS between 18 and 65 years and hospitalized
2- Receiving 1 gram of corticosteroid pulse daily for at least 3 days
3- Patient consent to participate in the study
Exclusion criteria:
1- Presence or history of peptic ulcer disease or gastroesophageal reflux disease or inflammatory bowel diseases
2- Simultaneous administration of other drugs that cause damage to the gastrointestinal mucosa and increase the risk of ulcers
3-Receiving acid-suppressing drugs such as PPIs and H2R antagonists in a recent week
4- Acute or chronic renal and hepatic failure clcr<30 , child-pughscore<2
5- Pregnancy and lactation
6-Patients who are receiving IVIG or plasma exchange at the same time, except for the corticosteroid pulse.
The occurrence of dyspepsia symptoms, The need for using Famotidine, The duration of corticosteroid pulse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201210049674N1
Registration date:2020-12-29, 1399/10/09
Registration timing:registered_while_recruiting
Last update:2020-12-29, 1399/10/09
Update count:0
Registration date
2020-12-29, 1399/10/09
Registrant information
Name
Mina Hejazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6535 2392
Email address
m-hejazi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of omeprazole and placebo in the prevention of acute gastrointestinal events in hospitalized patients with multiple sclerosis receiving corticosteroid pulse: A Prospective randomized double-blind placebo control clinical trial
Public title
Comparison of the effects of omeprazole in prevention of gastrointestinal events in patients with multiple sclerosis receiving corticosteroid pulse therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with recurrent types of MS between 18 and 65 years and hospitalized
Receive 1 gram of corticosteroid pulse daily for at least 3 days
Patient consent to participate in the study
Exclusion criteria:
Presence or history of peptic ulcer disease or gastroesophageal reflux disease or inflammatory bowel disease such as colitis and Crohn's disease
Simultaneous administration of other drugs that cause damage to the gastrointestinal mucosa and increase the risk of ulcers and bleeding, such as oral corticosteroids, NSAIDs, anticoagulants, antiplatelets, etc
Receive acid-suppressing drugs such as PPIs and H2R antagonists in the last week
Acute or chronic renal and hepatic failure clcr<30 , child-pughscore<2
Pregnancy and lactation
Patients receiving IVIG or plasma exchange at the same time, other than a corticosteroid pulse.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization with size of 4 based on a table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, the physician, and the person monitoring the patient are blind to the intervention.
This study is a double blinded study
The main researcher studies the coding of drugs in groups a and b and is aware of the drug and the placebo of the cans, but remains blind as to which patient receives which drug package code.
Researchers who accept patients and give them medication and perform evaluation tests, the data analyzer and patients, are blind to the study groups.
It should be noted that the drug and placebo are exactly the same in appearance.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Institute of Pharmaceutical Sciences- Tehran University of Medical Sciences
Street address
16 Azar Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences, 2nd floor, Unit 1-219