Status:
COMPLETED
Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation
Lead Sponsor:
Apimeds, Inc.
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
35-85 years
Phase:
PHASE2
Brief Summary
The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00949754
Start Date
October 1 2009
End Date
April 1 2010
Last Update
May 5 2010
Active Locations (4)
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1
Radiant Research Inc.
Pinellas Park, Florida, United States, 33781
2
Radiant Research - Chicago
Chicago, Illinois, United States, 60657
3
Radiant Research - Columbus
Columbus, Ohio, United States, 43212
4
Radiant Research - San Antonio
San Antonio, Texas, United States, 78217