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Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury: A randomized, double-blind, pilot study

Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury: A randomized, double-blind, pilot study - Preventive effect of ecabet sodium on low-dose aspirin-induced small intestinal mucosal injury

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033984
Enrollment
30
Registered
2018-09-01
Start date
2011-10-04
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

LDA-induced small intestinal mucosal injury

Interventions

The subjects in group A received LDA (100 mg) once daily. The subjects in group B received LDA and 4.0 g of ES (1.0 g four times daily).

Sponsors

Osaka medical college
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) freely provided informed consent on the basis of their full understanding of the study protocol, and 2) had no history of medication use during the month before enrolment in the study

Exclusion criteria

Exclusion criteria: 1) history of peptic ulcer or gastrointestinal bleeding; 2) significant hepatic, renal, heart, or respiratory disease; 3) history of gastrointestinal surgery other than appendectomy; 4) use of oral histamine H2-receptor antagonists, gastrointestinal kinetic agents, and gastric mucoprotective drugs within 2 weeks before the study; 5) use of oral non-steroidal anti-inflammatory drugs (NSAIDs), steroids, anticholinergic drugs, anticancer drugs, or antithrombotic drugs within 4 weeks prior; 6) alcohol or chemical dependency; 7) history of gastrointestinal obstruction; 8) refusal to consent to the surgery that would be required if the capsule endoscope was retained in the body; and 9) determination by the investigator, at his/her discretion, that a subject was ineligible for participation in the study for any reason.

Design outcomes

Primary

MeasureTime frame
Severity of small intestinal mucosal injury using small bowel capsule endoscopy

Countries

Japan

Contacts

Public ContactKazuhiro Ota

Osaka medical college Second department of internal medicine

clash_kaz@yathoo.co.jp072-683-1221

Outcome results

None listed

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