Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation (HBV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00949754
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : May 5, 2010
Information provided by:
Apimeds, Inc.

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

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: honeybee venom (Apitoxin (Korea) Apitox (USA)) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Active Comparator: histamine
histamine in saline administered ID as active control for Apitox
Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))
multiple intradermal injections of 100 ug pure honeybee venom
Other Name: Apitoxin (Korea) Apitox (USA)
Experimental: Apitox pure honeybee venom
ID study drug
Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))
multiple intradermal injections of 100 ug pure honeybee venom
Other Name: Apitoxin (Korea) Apitox (USA)

Primary Outcome Measures :
  1. WOMAC [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00949754

United States, Florida
Radiant Research Inc.
Pinellas Park, Florida, United States, 33781
United States, Illinois
Radiant Research - Chicago
Chicago, Illinois, United States, 60657
United States, Ohio
Radiant Research - Columbus
Columbus, Ohio, United States, 43212
United States, Texas
Radiant Research - San Antonio
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Apimeds, Inc.
Study Chair: Christopher MH Kim, M.D. Apimeds, CEO
Study Director: Robert Brooks, PhD Apimeds, Inc, US Chief Operating Officer

Responsible Party: Robert Brooks PhD, Chief Operating Officer US, Apimeds, Inc. Identifier: NCT00949754     History of Changes
Other Study ID Numbers: API092
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: May 5, 2010
Last Verified: May 2010

Keywords provided by Apimeds, Inc.:
honeybee venom

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs