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Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury.

Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury. - Prospective, randomized, double-blind, controlled trial of the healing effect of Polaprezinc for NSAIDs induced small bowel injury.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001538
Enrollment
40
Registered
2008-12-01
Start date
2008-12-01
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

NSAIDs-induced small bowel injury

Interventions

Polaprezinc placebo

Sponsors

Division of Gastroenterology,Department of Internal Medicine, Keio University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients who have taken NSAIDs for more than one month and who will take NSAIDs for one month after enrollment.

Exclusion criteria

Exclusion criteria: 1) The patients with dysphagia. 2) Pregnant or lactating women. 3) The patients who have history of the ileus or stricture or fistula of the intestine. 4) The patients who have Crohn's disease, Behchet's disease. 5) The patient with pacemaker or other medical electronic equipment. 6) The patient who have taken mucoprotective agent or took it within one month before enrollment. 7) The patient who have severe anemia (less than Hb 8.0mg/dl) or a hematemesis or a melena. 8) The patients who have taken antibiotics or took it within one month before enrollment. 9) The patients who have severe hiatal hernia. 10) The patient who take COX-2 inhibitor (celecoxib) only or low-dose aspirin only. 11) The patients who have severe illness. 12) The patients who have history of abdominal operation or radiation therapy.

Design outcomes

Primary

MeasureTime frame
Capsule endoscopic findings (number of ulcers/erosions and red spots)

Secondary

MeasureTime frame
Laboratory data and subjective symptom

Countries

Japan

Contacts

Public ContactNaoki Hosoe, M.D., Ph.D.

Keio University Division of Gastroenterology

hosenao@db3.so-net.ne.jp03-3353-1211

Outcome results

None listed

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