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Efficacy of irsogladine maleate and for the prevention of gastric mucosal lesions induced by aspirin: a randomized, controlled, prospective study.

Efficacy of irsogladine maleate and for the prevention of gastric mucosal lesions induced by aspirin: a randomized, controlled, prospective study. - Preventive efficacy for aspirin induced gastric mucosal lesions by irsogladine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009230
Enrollment
45
Registered
2012-10-31
Start date
2012-10-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Gastritis

Interventions

Aspirin 100mg/day p.o. for 2 weeks Aspirin 100mg/day and Irsogladine 4mg/day p.o. for 2 weeks Aspirin 100mg/day and Lansoprazole 15mg/day p.o. for 2 weeks

Sponsors

Department of Gastroenterology, Faculty of Medicine, Oita University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: H. pylori negative healthy subjects aged from 20 to 65 years when the written informed consent is obtained

Exclusion criteria

Exclusion criteria: 1)Subjects with a history of peptic ulcer or gastrointestinal bleeding 2)Subjects with significant hepatic disease, renal disease, heart disease, or respiratory disease 3)Subjects with a history of gastrointestinal surgery other than appendectomy 4)Subjects orally taking or planning to orally take drug other than antiulcer drug or NSAIDs 5)Pregnancy or Lactation 6)Subjects whom otherwise the investigator determined ineligible as the subject

Design outcomes

Primary

MeasureTime frame
LANZA scores at 2 weeks of the treatment

Countries

Japan

Contacts

Public ContactKazuhiro Mizukami

Faculty of Medicine, Oita University Department of Gastroenterology

mizkaz0809@oita-u.ac.jp097-586-6193

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026