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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201210049674N1
Enrollment
102
Registered
2020-12-29
Start date
2020-08-22
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Multiple Sclerosis. Condition 2: Gastrointestinal problems. Multiple sclerosis Disease of digestive system, unspecified

Interventions

Intervention 1: Intervention group: Capsule Omeprazole 20 mg (Sobhan company) once daily. Intervention 2: Control group: Capsule placebo once daily.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Duration of receiving corticosteroid pulse. Timepoint: At the time of discharge from the hospital. Method of measurement: Patient medical report.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMina Hejazi

Tehran University of Medical Sciences

m-hejazi@student.tums.ac.ir+98 21 6695 4709

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026