Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

Study Overview
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Brief Summary
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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
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feasibility and Site selection has been completed in the US and India

Official Title
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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

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Biological: Apitox, purified honeybee toxin, lyophilized in saline
* Biological: histamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: osteoarthritis of one or both knees on stable NSAID or none due to intolerance women either post menopausal or on stable birth control no clinically significant disease or or abnormal laboratory values signed informed consent, communicate effectively, understand and comply with all study requirements Exclusion Criteria: serious or unstable medical or psychological condition known sensitivity to honeybee venom, histamine or lidocaine history of asthma any clinically significant ECG abnormalities any clinically significant laboratory values OOR history of drug or alcohol abuse history of joint injury and forms of inflammatory arthritis

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Apitox, purified honeybee toxin, injections<br>active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline' | Biological: Apitox, purified honeybee toxin, lyophilized in saline<br>* intradermal injections of 0.1mg apitox in 0.1ml WFI over 12 weeks treatment period, injections twice weekly range from 1 to 20 injections<br>* Other names: Apitoxin in Korea;|
| Placebo Comparator: histamine injection<br>the histamine injection produces a similar local effect of pain and erythema as the active drug | Biological: histamine<br>* imitates pain and erythema of honeybee venom<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC | WOMAC | from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PhGA | physcians global assessment | from 4 wks global assessment through 12 wks | 
| PGA | patients global assessmen | from 4 wks throught the 12 wk treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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honeybee toxin, Apitox, pain, inflammation, osteoarthritis, Apitoxin