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Evaluation of the effect of famotidine in preventing gastrointestinal complications of pulse glucocorticoid therapy

Evaluation of the efficacy of famotidine compared to placebo in preventing acute gastrointestinal symptoms in patients with multiple sclerosis undergoing pulse glucocorticoid therapy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250211064703N1
Enrollment
102
Registered
2025-04-12
Start date
2025-04-05
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Condition 1: Gastrointestinal side effects of glucocorticoid pulse therapy in MS relapse. Condition 2: Multiple sclerosis. Condition 3: Gastrointestinal symptoms. Glucocorticoids and synthetic analogues Multiple sclerosis Disease of digestive system, unspecified

Interventions

Intervention 1: Intervention group: During the period of receiving pulse glucocorticoid therapy, patients will take one 40 mg famotidine tablet (manufatured by Shahre Daru) daily. Intervention 2: Cont

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with Relapsing-Remitting Multiple Sclerosis aged 18 to 65 years, hospitalized in the Neurology Department of Sina Hospital Candidates for receiving pulse corticosteroid therapy at a dose of 1 gram per day for at least 3 days Written and informed consent obtained from the patient for participation in the study

Exclusion criteria

Exclusion criteria: Presence or history of peptic ulcer disease (PUD), gastroesophageal reflux disease (GERD), or inflammatory bowel diseases such as colitis and Crohn's disease Concurrent use of other medications that cause gastrointestinal mucosal damage and increase the risk of ulcers and bleeding, such as oral corticosteroids, non steroid anti-inflammatory drugs, anticoagulants, antiplatelets Use of acid-suppressing medications such as proton pump inhibitors and histamin type 2 receptor antagonists within the past week Severe chronic kidney disease (CrCl < 30) or moderate to severe hepatic failure (Child-Pugh score B and C) Pregnancy and breastfeeding Patients who, in addition to pulse corticosteroids therapy, are simultaneously receiving IVIG or undergoing plasma exchange.

Design outcomes

Primary

MeasureTime frame
Stool characteristics. Timepoint: At the time of admission, at the time of discharge, two weeks after discharge. Method of measurement: Based on the score in the Abdominal symptoms questionnaire: none, mild, moderate, quite a lot, severe, very severe, unbearable.;Antacid consumption as needed. Timepoint: At the time of discharge. Method of measurement: Recording and assessment of the amount of antacid consumed.;Abdominal pain. Timepoint: At the time of admission, at the time of discharge, two weeks after discharge. Method of measurement: Based on the score in the Abdominal symptoms questionnaire: none, mild, moderate, quite a lot, severe, very severe, unbearable.;Epigastric pain. Timepoint: At the time of admission, at the time of discharge, two weeks after discharge. Method of measurement: Based on the score in the Abdominal symptoms questionnaire: none, mild, moderate, quite a lot, severe, very severe, unbearable.;Heartburn. Timepoint: At the time of admission, at the time of discharge, two weeks after discharge. Method of measurement: Based on the score in the Abdominal symptoms questionnaire: none, mild, moderate, quite a lot, severe, very severe, unbearable.;Regurgitation. Timepoint: At the time of admission, at the time of discharge, two weeks after discharge. Method of measurement: Based on the score in the Abdominal symptoms questionnaire: none, mild, moderate, quite a lot, severe, very severe, unbearable.;Abdominal rumbling. Timepoint: At the time of admission, at the time of discharge, two weeks after discharge. Method of measurement: Based on the score in the Abdominal symptoms questionnaire: none, mild, moderate, quite a lot, severe, very severe, unbearable.;Bloating. Timepoint: At the time of admission, at the time of discharge, two weeks after discharge. Method of measurement: Based on the score in the Abdominal symptoms questionnaire: none, mild, moderate, quite a lot, severe, very severe, unbearable.;Nausea. Timepoint: At the time of admission, at th

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHooshyar Honarmand

Tehran University of Medical Sciences

Hooshyar1978@gmail.com+98 21 8832 2025

Outcome results

None listed

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