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Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

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: NCT01112722
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : December 13, 2016
Information provided by (Responsible Party):
Apimeds, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Biological: Apitox, purified honeybee toxin, lyophilized in saline Biological: histamine Phase 3

Detailed Description:
feasibility and Site selection has been completed in the US and India

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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 Name: 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

Primary Outcome Measures :
  1. WOMAC [ Time Frame: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up ]

Secondary Outcome Measures :
  1. PhGA [ Time Frame: from 4 wks global assessment through 12 wks ]
    physcians global assessment

  2. PGA [ Time Frame: from 4 wks throught the 12 wk treatment ]
    patients global assessmen

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
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): NCT01112722

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United States, Alabama
Functional Research LLC
Gulf Shores, Alabama, United States, 36542
United States, Arizona
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 87512
United States, California
SC Clinical Research Inc.
Garden Grove, California, United States, 92844
Axis Clinical Trials
Los Angeles, California, United States, 90036
Westlake Medical Research
Thousand Oaks, California, United States, 91360
SC Clinical Research Inc.
Upland, California, United States, 91786
United States, Florida
Schrock Orthopedics Research
Ft Lauderdale, Florida, United States, 33316
AppleMed Research Inc.
Miami, Florida, United States, 33155
Radiant Research Inc.
Pinellas Park, Florida, United States, 33781
United States, Massachusetts
Beacon Clinical
Brockton, Massachusetts, United States, 02301
United States, Ohio
Radiant Research Inc Columbus
Columbus, Ohio, United States, 43212
United States, Oklahoma
Hillcrest Clinical Research
Olahoma City, Oklahoma, United States, 73119
United States, Tennessee
PMG Research of Knoxville
Knoxville, Tennessee, United States, 37912
PMG Research of Knoxville
Knoxville, Tennessee, United States, 37938
United States, Texas
Tekton Research
Austin, Texas, United States, 78745
Sponsors and Collaborators
Apimeds, Inc.
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Study Chair: Christopher M. H. Kim, M.D. Apimeds, CEO
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Responsible Party: Apimeds, Inc. Identifier: NCT01112722    
Other Study ID Numbers: 01-13
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Apimeds, Inc.:
honeybee toxin
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs