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 range

30 Years – 85 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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