Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation

Osteoarthritis of the Knee Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949754
• Other study ID #: API092
• Status: Completed
• Phase: Phase 2
• First received: July 28, 2009
• Last updated: May 4, 2010
• Start date: October 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Apimeds, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• honeybee venom (Apitoxin (Korea) Apitox (USA))
multiple intradermal injections of 100 ug pure honeybee venom

Locations

Country	Name	City	State
United States	Radiant Research - Chicago	Chicago	Illinois
United States	Radiant Research - Columbus	Columbus	Ohio
United States	Radiant Research Inc.	Pinellas Park	Florida
United States	Radiant Research - San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Apimeds, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC		14 days	No