NCT04082000

Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 for Treating Diabetic Neuropathy

A Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 Sublingual Drops for Treating Diabetic Neuropathy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Breath of Life International Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled Phase 2a Study Examining the Safety and Efficacy of BOL-DP-o-04 for Treating Diabetic Neuropathy

Detailed description

A Phase 2a, two-center, randomized, double-blind, placebo-controlled study in which subjects will be randomized to receive either BOL-DP-o-04 or placebo in addition to Standart of Care. The study evaluates the effect of BOL-DP-o-04 for Diabetic Neuropathy. The study includes a screening period up to three weeks followed by a 12-week treatment period

Conditions

• Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	BOL-DP-o-04	BOL-DP-o-04
DRUG	Placebo	Placebo

Timeline

• Start date: 2019-04-15
• Primary completion: 2020-11-04
• Completion: 2020-11-04
• First posted: 2019-09-09
• Last updated: 2021-03-24

Locations

1 site across 1 country: Israel