NCT04666714

Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain

National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Praga formulation in the treatment of neuropathic pain.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Praga formulation	Praga formulation tablet
OTHER	Placebo pregabalin 75mg	Placebo pregabalin 75mg tablet
OTHER	Placebo Pregabalin 150mg	Placebo Pregabalin 150mg tablet
DRUG	Pregabalin 75mg	Pregabalin 75mg tablet
DRUG	Pregabalin 150mg	Pregabalin 150mg tablet
OTHER	Placebo Praga formulation	Placebo Praga formulation tablet

Timeline

• Start date: 2023-05-15
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2020-12-14
• Last updated: 2025-03-14

Locations

1 site across 1 country: Brazil