drugset / Trial / NCT01112722

Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

NCT01112722 ↗

Phase 3 Completed 363 enrolled Apimeds, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study will identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global Assessments and primary efficacy measure of relief of pain and inflammation over a 12 week treatment period after randomization into the trial. Secondary efficacy is improvement of mobility Treatment effect will be compared in a 2-1 Apitox vs active control

Timeline

Start
2013-12
Primary completion
2016-11
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Apitox Unknown 0.1 mg Intrathecal

Indications