Trial intelligence / Profile preview

N0750 for Painful Diabetic Peripheral Neuropathy (ENFORCE)

NCT06715462Phase 3

Key facts

Status: Withdrawn
Start: Apr 2026
Primary completion: Mar 2028
Countries: 1
Sponsor: Eurofarma

Drugs: N0750
Conditions: diabetic peripheral neuropathy (DPN)

Overview

Phase 3, randomised, triple-blind trial of N0750 in diabetic peripheral neuropathy (DPN) (3 arms), sponsored by Eurofarma. Primary endpoint: Numerical Rating Scale at 84 days. Planned start Apr 2026; status: withdrawn.

Design

3 arms

Study design: RandomizedTriple-blind

N0750
N0750 experimental arm
Cymbalta
Duloxetine active comparator arm
Lyrica
Pregabalin active comparator arm

Endpoints

Primary

Numerical Rating Scale84 days

Secondary

Pain Reduction84 days
Patient Global Impression of Change84 days
Safety Profile84 days

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