Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis (NCT01112722) | Clinical Trial Compass
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.
1This trial tested something called Apitox, which is a honeybee toxin injected to treat knee osteoarthritis pain — is this kind of treatment something that has ever been considered for my situation, and what does my doctor think about how it compares to what I'm already doing or could do?
2Since this was a Phase 3 trial that has already completed, does my doctor know whether the results were published and what they showed on the WOMAC score, which measures pain, stiffness, and physical function in knee osteoarthritis?
3Bee venom injections could potentially cause allergic reactions, including serious ones — given my personal health history, is that a safety concern my doctor thinks I should weigh carefully if a similar treatment were ever an option for me?
4The trial measured outcomes using the WOMAC scale — can my doctor explain what a meaningful improvement on that scale would actually look like day-to-day for someone with my level of knee osteoarthritis?
5Before considering any experimental or newer approaches like bee venom therapy, are there standard treatments I haven't tried yet that my doctor would recommend exhausting first?
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
1
WOMAC
Timeframe: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up