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

NCT06715462 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-12-18

No results posted yet for this study

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).

Conditions

  • Painful Diabetic Peripheral Neuropathy (PDPN)

Interventions

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

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06715462 on ClinicalTrials.gov