Trial | NCT00949754  Report issue

Title

Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation
A Multi-Center, Randomized, Double Blind, Active-Controlled, Parallel Group Clinical Study to Evaluate the Dose Effect of Intradermal Injections of Apitox vs. Histamine in Subjects With Osteoarthritis Symptoms of the Knee

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    bee venom ...

  • Study Participants

    40
The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.
Study Started
Oct 31
2009
Primary Completion
Mar 31
2010
Study Completion
Apr 30
2010
Last Update
May 05
2010
Estimate

Drug honeybee venom (Apitoxin (Korea) Apitox (USA))

multiple intradermal injections of 100 ug pure honeybee venom

  • Other names: Apitoxin (Korea) Apitox (USA)

histamine Active Comparator

histamine in saline administered ID as active control for Apitox

Apitox pure honeybee venom Experimental

ID study drug

Criteria 

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
No Results Posted