Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation
Phase 2
Completed
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))
- Registration Number
- NCT00949754
- Lead Sponsor
- Apimeds, Inc.
- Brief Summary
The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description histamine honeybee venom (Apitoxin (Korea) Apitox (USA)) histamine in saline administered ID as active control for Apitox Apitox pure honeybee venom honeybee venom (Apitoxin (Korea) Apitox (USA)) ID study drug
- Primary Outcome Measures
Name Time Method WOMAC 14 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Radiant Research - Columbus
🇺🇸Columbus, Ohio, United States
Radiant Research Inc.
🇺🇸Pinellas Park, Florida, United States
Radiant Research - Chicago
🇺🇸Chicago, Illinois, United States
Radiant Research - San Antonio
🇺🇸San Antonio, Texas, United States