drugset / Trial / NCT04799041

Gonyautoxin 2/3 in the Treatment of Acute Back Pain: A Clinical Proof-of-concept Study

NCT04799041 ↗

Phase 1/2 Completed 30 enrolled Algenis SpA
RandomizedParallel-groupDouble-blindTreatment

Summary

This was an interventional, double-blind, placebo controlled, randomized, single dose, proof-of-concept study. It was a single-center clinical trial. The purpose of the study was to explore the clinical efficacy and safety of a single local IM injection of gonyautoxin 2/3 (GTX 2/3) compared to placebo in decreasing pain and improving lumbar functionality at short term follow-up in adult patients with acute low back pain, without radiculopathy.

Timeline

Start
2019-10-11
Primary completion
2020-03-19
Completion
2020-03-19

Drugs

EvaluationDrugModalityDoseRoute
Comparator GTX 2/3 Unknown 80 ug Intramuscular

Indications

No indication recorded.