Prospective, randomized, double-blind, controlled study for the incidence of small bowel mucosal injury caused by selective COX-2 inhibitor in healthy volunteers

Prospective, randomized, double-blind, controlled study for the incidence of small bowel mucosal injury caused by selective COX-2 inhibitor in healthy volunteers - Clinical trial for the incidence of small bowel mucosal injury by selective COX-2 inhibitor

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003871

Enrollment

Registered

2010-07-05

Start date

2010-04-01

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

Small bowel mucosal injury

Interventions

Subjects in celecoxib group are administered celecoxib 200mg twice per day for two weeks. Subjects in meloxicam group are administered meloxicam 10mg once per day for two weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers obtained written informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects with a history of peptic ulcers 2) Subjects treated by corticosteroid (>10mg of prednisolone) 3) Subjects treated continuously with NSAIDs 4) Subjects treated with aspirin 5) Subjects with a history of aspirin-induced asthma 6) Subjects allergic to sulufonamids 7) Subjects treated with anti-ulcer drugs (misoprostol, rebamipide, teprenone, etc) 8) Subjects with stenosis of gastrointestinal tract or severe adhesion 9) Subjects with malignancy, psychosis, severe hepatic, renal dysfunction, heart disease, or hematologic disease 10) Pregnant and nursing women 11) Subjects with other disorders who are judged as inappropriate for the participation of the study

Design outcomes

Primary

Measure	Time frame
The number and incidence of small bowel pathologies (ulcer, hemorrhage and mucosal break) under capsule endoscopy after 2 weeks medication.	—

Secondary

Measure	Time frame
Abdominal symptoms and laboratory data including anemia	—

Countries

Japan

Contacts

Public ContactMotohiro Esaki, Yuji Maehata

Graduate School of Medical Sciences, Kyushu University Department of Medicine and Clinical Science

092-642-5261

Outcome results

None listed

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