NCT06715462

Efficacy and Safety of the N0750 Compared to Monotherapies in the Treatment of Painful Diabetic Peripheral Neuropathy

A Phase 3, Prospective, Adaptive, Randomized, Double-blind, Triple-masked, Parallel, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the N0750 Compared to Monotherapies in the Treatment of Painful Diabetic Peripheral Neuropathy

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A phase 3, prospective, adaptive, randomized, multicenter, double-blind, triple-masked, parallel clinical trial to evaluate the efficacy and safety of N0750 in relieving pain associated with painful diabetic peripheral neuropathy (PDPN).

Detailed description

The objective of this clinical trial is to demonstrate the superiority of treatment with N0750 compared to monotherapy with Cymbalta® (duloxetine hydrochloride 60 mg, delayed-release capsule) and Lyrica® (pregabalin 150 mg, hard capsule, given twice daily for a total daily dose of 300 mg). The clinical trial population will consist of patients of both sexes, diagnosed with PDPN for at least 3 months, confirmed by the presence of signs and symptoms in the Neuropathic Impairment Score (NIS) and Neuropathic Symptom Score (NSS), respectively, and with pain ≥ 6 points on the Numerical Scale (11 points \[0-10\]). The primary objective of this clinical trial is to evaluate the reduction in pain intensity associated with Diabetic Peripheral Neuropathy (DPN). The primary endpoint of the trial is the change from baseline (Randomisation Visit \[RV\]) at the end of 12 weeks of treatment (Visit 4) in the weekly mean pain intensity in the last 24 hours, as assessed by the Numerical Rating Scale (11 points \[0-10\]).

Conditions

• Painful Diabetic Peripheral Neuropathy (PDPN)

Interventions

Type	Name	Description
DRUG	N0750	N0750 caps + Cymbalta placebo caps + Lyrica placebo caps
DRUG	Cymbalta®	Cymbalta® caps + N0750 placebo caps + Lyrica placebo caps
DRUG	Lyrica®	Lyrica® caps + N0750 placebo caps + Cymbalta placebo caps

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2024-12-04
• Last updated: 2025-12-18

Locations

1 site across 1 country: Brazil