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The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma

The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma - The efficacy and safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020701
Enrollment
40
Registered
2016-01-22
Start date
2005-03-10
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

reflux esophagitis associated with systemic scleroderma

Interventions

Rabeprazole sodium 1 tablet a day will be added to subjects whose symptom does not improve with 1 tablet a day. The study will continue until subjects meet discontinuance criteria.

Sponsors

Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with systemic sclerosis who have reflux esophagitis diagnosed by upper gastrointestinal endoscopy or esophagus scintigraphy and daily 10mg of oral rabeprazole sodium is not effective for more than two months. Patients who have no malignant lesions in the upper-gastrointestinal tract confirmed by endoscopy. Patients who give written informed consent.

Exclusion criteria

Exclusion criteria: Patients who have a severe difficulty swallowing and who are unable to take orally the tablet. Patients who are judged to be inappropriate as a subject by physicians.

Design outcomes

Primary

MeasureTime frame
The efficacy of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma

Secondary

MeasureTime frame
The safety of rabeprazole sodium 20mg against reflux esophagitis associated with systemic scleroderma

Countries

Japan

Contacts

Public ContactYasuhito Hamaguchi

Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University Dermatology

yasuhito@med.kanazawa-u.ac.jp076-265-2343

Outcome results

None listed

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