NCT05619328

A Prospective Clinical Trial to Evaluate the Efficacy and Safety of Neurotropic B-Vitamins in Clinically Diagnosed Peripheral Sensory Polyneuropathy of Different Etiologies.

A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of the Product Vitamins B1 (100mg), B6 (100 mg), Plus B12 (5 mg) in Tablets in Subjects With Clinically Diagnosed PerIpheral Sensory polyNeuropathy of Different etiologieS (PINS Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to investigate the efficacy of the Test Product in subjects with clinically diagnosed peripheral sensory polyneuropathy of different etiologies compared to placebo.

Detailed description

This prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase III clinical study is designed to investigate the efficacy and safety of the Test product versus placebo in male and non-pregnant female subjects with clinically diagnosed peripheral sensory polyneuropathy of different etiologies aged 18 to 70 years. The study will be conducted in 17 sites in Mexico. 318 patients with clinically diagnosed symptoms of peripheral sensory polyneuropathy of different etiologies who fulfill the inclusion and exclusion criteria will be enrolled and randomized in a 1:1 ratio to receive either oral vitamin B combination daily or matching placebo for 120 days. The primary and secondary outcome measures will be evaluated at each post-Screening visit. Exploratory outcomes, and safety/tolerability/treatment satisfaction assessments will be evaluated as per schedule of activities. Approvals were obtained from Local Ethics Committees and from Mexican Regulatory Authority (COFEPRIS).

Conditions

• Peripheral Sensory Neuropathy of Different Etiologies

Interventions

Type	Name	Description
DRUG	Vitamin B combination tablet	Once daily, with some liquid with or after a meal
DRUG	Placebo Tablet	Once daily, with some liquid with or after a meal

Timeline

• Start date: 2022-09-06
• Primary completion: 2023-11-02
• Completion: 2023-11-02
• First posted: 2022-11-16
• Last updated: 2023-11-28

Locations

1 site across 1 country: Mexico