CompletedPhase 3

Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

United States363 participantsStarted 2013-12

Plain-language 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

Who can participate

Age range30 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

WOMAC

Timeframe: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up

Trial details

NCT IDNCT01112722

SponsorApimeds, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11

View on ClinicalTrials.gov More Osteoarthritis of the Knee trials