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Incidence of esophagitis, peptic ulcers and small intestinal mucosal lesions induced by loxoprofen, etodolac and celecoxib in healthy volunteers: a prospective randomized comparative trial

Incidence of esophagitis, peptic ulcers and small intestinal mucosal lesions induced by loxoprofen, etodolac and celecoxib in healthy volunteers: a prospective randomized comparative trial - Clinical trial for the incidence of gastrointestinal lesions by selective COX-2 inhibitor

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009475
Enrollment
33
Registered
2012-12-04
Start date
2012-12-10
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

NSAID induced gastrointestinal mucosal lesions

Interventions

Famotidine 20 mg/day b.i.d. and loxoprofen 180 mg/day t.i.d for 2 weeks by oral administration Famotidine 20 mg/day b.i.d. and etodolac 400 mg/day b.i.d for 2 weeks by oral administration Famotidine

Sponsors

Second Department of Internal Medicine, Osaka Medical College
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy adults who are 20 years or older, and less than 80 years of age at the time of obtaining informed consent 2) Subjects from whom fully informed written consent based on their full understanding and their own voluntary will was obtained at the commencement of this study

Exclusion criteria

Exclusion criteria: 1) Subjects who have active peptic ulcer or gastrointestinal bleeding and need endoscopic treatment immediately 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 loxoprofen, etodolac, celecoxib or famotidine 5) Subjects with alcohol or chemical dependencies 6) Subjects with a history of intestinal obstruction, or person with suspected gastrointestinal obstruction on other tests 7)Subjects who cannot agree that surgery may be required if capsule endoscope retained in the body 8) Subjects whom otherwise the investigator determined ineligible as the subject

Design outcomes

Primary

MeasureTime frame
The numbers of small intestinal mucosal breaks evaluated by capsule endoscopy

Countries

Japan

Contacts

Public ContactEiji Umegaki

Osaka Medical College Second Department of Internal Medicine

Outcome results

None listed

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