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

May 4, 2010 updated by: Apimeds, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research Inc.
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Radiant Research - Chicago
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Radiant Research - Columbus
    • Texas
      • San Antonio, Texas, United States, 78217
        • Radiant Research - San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

31 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Apitoxin (Korea) Apitox (USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
WOMAC
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apimeds, Inc.

Investigators

  • Study Chair: Christopher MH Kim, M.D., Apimeds, CEO
  • Study Director: Robert Brooks, PhD, Apimeds, Inc, US Chief Operating Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

July 28, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (Estimate)

July 30, 2009

Study Record Updates

Last Update Posted (Estimate)

May 5, 2010

Last Update Submitted That Met QC Criteria

May 4, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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