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J-DIRECT: Diclofenac cream to prevent capecitabine-related hand-foot syndrome
jRCTs031240705Phase 3Recruiting
- Start
- Apr 2025
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in Erythrodysesthesia syndrome (PPE), Sensory neuropathy (SN) and adverse event comparing Topical diclofenac 0.1% cream with Placebo cream (2 arms). Primary endpoint: Incidence of grade ≥ 2 hand-foot syndrome within three months. Started Apr 2025; status: recruiting.
02
Drugs
diclofenac
03
Conditions
Erythrodysesthesia syndrome (PPE)Sensory neuropathy (SN)adverse event
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