NCT01112722

Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

A Multicenter, Randomized, Double Blind, Active Controlled, Parallel Group, Clinical Study, to Evaluate the Safety and Efficacy of Apitox vs Histamine in Subjects With Refractory Osteoarthritis Pain and Inflammation of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Apimeds, Inc. · Industry
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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

Detailed description

feasibility and Site selection has been completed in the US and India

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
BIOLOGICAL	Apitox, purified honeybee toxin, lyophilized in saline	intradermal injections of 0.1mg apitox in 0.1ml WFI over 12 weeks treatment period, injections twice weekly range from 1 to 20 injections
BIOLOGICAL	histamine	imitates pain and erythema of honeybee venom

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2010-04-28
• Last updated: 2016-12-13

Locations

15 sites across 1 country: United States