Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

Apimeds

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis of the Knee

Treatments: Biological: histamine; Biological: Apitox, purified honeybee toxin, lyophilized in saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01112722

01-13

Details and patient eligibility

About

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

Full description

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

Enrollment: 363 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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363 participants in 2 patient groups, including a placebo group

Apitox, purified honeybee toxin, injections

Active Comparator group

Description:

active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline'

Treatment:

Biological: Apitox, purified honeybee toxin, lyophilized in saline

histamine injection

Placebo Comparator group

Description:

the histamine injection produces a similar local effect of pain and erythema as the active drug

Treatment:

Biological: histamine