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A phase 2 study of SR-0379 in patients with cutaneous ulcer (pressure ulcer, diabetic ulcer)

A phase 2 study of SR-0379 in patients with cutaneous ulcer (pressure ulcer, diabetic ulcer)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223939
Enrollment
120
Registered
2018-06-12
Start date
2018-07-04
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

Cutaneous ulcer (pressure ulcer, diabetic ulcer)

Interventions

investigational material(s) Generic name etc : SR-0379 INN of investigational material : - Therapeutic category code : 269 Other agents for epidermis Dosage and Administration for Investigational mate

Sponsors

Shionogi & Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients whose major axis of ulcer is 1 cm or more and 6 cm or less, and depth of ulcer is classified into d2, D3, or D4 referring to the DESIGN-R(R) for evaluation of pressure ulcer (Japanese Society of Pressure Ulcers), etc.

Exclusion criteria

Exclusion criteria: Patients who have ulcer with apparent infection including flare, swelling, pus, malodor, or fever around the ulcer, etc.

Design outcomes

Primary

MeasureTime frame
efficacy The percent reduction in surface area of the ulcer

Secondary

MeasureTime frame
safety Percentage of patients with any adverse events, etc.

Countries

Japan

Outcome results

None listed

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