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IRCT20201210049674N1 IRCT 2020-12-29 Tehran University of Medical Sciences Comparison of the effects of omeprazole in prevention of gastrointestinal events in patients with multiple sclerosis receiving corticosteroid pulse therapy 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 2020-08-22 anticipated 102 Complete https://irct.ir/trial/52928 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization with size of 4 based on a table of random numbers, 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. 3 Condition 1: Multiple Sclerosis. Condition 2: Gastrointestinal problems. Intervention 1: Intervention group: Capsule Omeprazole 20 mg (Sobhan company) once daily. Intervention 2: Control group: Capsule placebo once daily. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Mina Hejazi
Department of Clinical Pharmacy, Tehran University of Medical Sciences, 16-Azar St., Enghelab Ave.,
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۱ +98 21 6695 4709 m-hejazi@student.tums.ac.ir Tehran University of Medical Sciences scientific Hooshyar Honarmand
Department of Clinical Pharmacy, Tehran University of Medical Sciences, 16-Azar St., Enghelab Ave., Tehran, Iran.
Tehran Iran (Islamic Republic of) 14176-14418 +98 21 6695 4709 hooshyar1978@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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. G35 K92.9 Multiple sclerosis Disease of digestive system, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Capsule Omeprazole 20 mg (Sobhan company) once daily Control group: Capsule placebo once daily Dyspepsia symptoms (including abdominal pain, nausea, heartburn, vomiting). Timepoint: Baseline, at the time of discharge from the hospital, 2 weeks after the discharge. Method of measurement: Direct questioning of the patient and, if necessary, clinical examination. The dose of Famotidine as PRN for dyspepsia management. Timepoint: At the time of discharge from the hospital, 2 weeks after the discharge. Method of measurement: Direct observing the patient medical report regarding the dose of drug receiving. Defecation changes. Timepoint: Baseline, at the time of discharge from the hospital, 2 weeks after the discharge. Method of measurement: Direct questioning of the patient and, if necessary, clinical examination. Duration of receiving corticosteroid pulse. Timepoint: At the time of discharge from the hospital. Method of measurement: Patient medical report. Tehran University of Medical Sciences Approved 2020-03-15 The Institute of Pharmaceutical Sciences- Tehran University of Medical Sciences 16 Azar Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences, 2nd floor, Unit 1-219 Tehran Tehran Iran (Islamic Republic of)