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Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs).

Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs). - Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by NSAIDs.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005362
Enrollment
13
Registered
2011-04-01
Start date
2011-04-01
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

Patients with rheumatoid arthritis with anemia taking NSAIDs

Interventions

Treatment with mesalazine

Sponsors

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Rheumatoid arthritis patients aged older than 20y and younger than 70 y who were taking NSAIDs for more than 3 mo and will take NSAIDs for the additional 8 w. 2)The patients with anemia (Hg levels lower than 13.8 g/dl (men) 12.0 g/dl(women) and without abnormalities in the liver and renal function tests.

Exclusion criteria

Exclusion criteria: Patients treated with mesalazine or salicylic acid 2 weeks proior to the entry of this study. Patients with escalating the dose of anti-rheumatoid arthritis drugs such as aspirins or proton pump inhitors. Patients took gastroprotective agents such as rebamipide, ecabet sodium, misoprostol. Patients being treated with high-dose corticosteroids (more than 15 mg/day of prednisolone. Patients treated with biologics 90 days prior to the entry of this study. Patients who were allergic to or suffered from side effects by mesalazine of salicylic acids. Patients incapable of swallowing capsule endoscopy. Patients suspicious of intestinal strictures. Patients with malignancies. Pregnancy or possible pregnancy. Patients with side effects by other previous clinical studies. Patients who were considered unsuitable for this study by doctors.

Design outcomes

Primary

MeasureTime frame
Endoscopic findings by capsule endoscopy. Side effects due to the mesalazine treatment.

Secondary

MeasureTime frame
Patients' joint and abdominal symptoms. Serum cytokines. Fecal calprotectin

Countries

Japan

Outcome results

None listed

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