Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

December 11, 2016 updated by: Apimeds, Inc.

A Multicenter, Randomized, Double Blind, Active Controlled, Parallel Group, Clinical Study, to Evaluate the Safety and Efficacy of Apitox vs Histamine in Subjects With Refractory Osteoarthritis Pain and Inflammation of the Knee

The study will identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global Assessments and primary efficacy measure of relief of pain and inflammation over a 12 week treatment period after randomization into the trial. Secondary efficacy is improvement of mobility Treatment effect will be compared in a 2-1 Apitox vs active control

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

feasibility and Site selection has been completed in the US and India

Study Type

Interventional

Enrollment (Actual)

363

Phase

  • Phase 3

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
    • Alabama
      • Gulf Shores, Alabama, United States, 36542
        • Functional Research LLC
    • Arizona
      • Tucson, Arizona, United States, 87512
        • Tucson Orthopaedic Institute
    • California
      • Garden Grove, California, United States, 92844
        • SC Clinical Research Inc.
      • Los Angeles, California, United States, 90036
        • Axis Clinical Trials
      • Thousand Oaks, California, United States, 91360
        • Westlake Medical Research
      • Upland, California, United States, 91786
        • SC Clinical Research Inc.
    • Florida
      • Ft Lauderdale, Florida, United States, 33316
        • Schrock Orthopedics Research
      • Miami, Florida, United States, 33155
        • AppleMed Research Inc.
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research Inc.
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Beacon Clinical
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Radiant Research Inc Columbus
    • Oklahoma
      • Olahoma City, Oklahoma, United States, 73119
        • Hillcrest Clinical Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37912
        • PMG Research of Knoxville
      • Knoxville, Tennessee, United States, 37938
        • PMG Research of Knoxville
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research

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

26 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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Apitox, purified honeybee toxin, injections
active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline'
Biological: Apitox, purified honeybee toxin, lyophilized in saline
intradermal injections of 0.1mg apitox in 0.1ml WFI over 12 weeks treatment period, injections twice weekly range from 1 to 20 injections
Other Names:
  • Apitoxin in Korea
Placebo Comparator: histamine injection
the histamine injection produces a similar local effect of pain and erythema as the active drug
Biological: histamine
imitates pain and erythema of honeybee venom

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC
Time Frame: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up
WOMAC
from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PhGA
Time Frame: from 4 wks global assessment through 12 wks
physcians global assessment
from 4 wks global assessment through 12 wks
PGA
Time Frame: from 4 wks throught the 12 wk treatment
patients global assessmen
from 4 wks throught the 12 wk treatment

Collaborators and Investigators

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

Sponsor

Apimeds, Inc.

Investigators

  • Study Chair: Christopher M. H. Kim, M.D., Apimeds, CEO

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

December 1, 2013

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 25, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 11, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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