Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis
NCT ID: NCT01112722
Last Updated: 2016-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
363 participants
INTERVENTIONAL
2013-12-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Apitox, purified honeybee toxin, injections
active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline'
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
histamine injection
the histamine injection produces a similar local effect of pain and erythema as the active drug
histamine
imitates pain and erythema of honeybee venom
Interventions
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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
histamine
imitates pain and erythema of honeybee venom
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
85 Years
ALL
No
Sponsors
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Apimeds, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher M. H. Kim, M.D.
Role: STUDY_CHAIR
Apimeds, CEO
Locations
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Functional Research LLC
Gulf Shores, Alabama, United States
Tucson Orthopaedic Institute
Tucson, Arizona, United States
SC Clinical Research Inc.
Garden Grove, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Westlake Medical Research
Thousand Oaks, California, United States
SC Clinical Research Inc.
Upland, California, United States
Schrock Orthopedics Research
Fort Lauderdale, Florida, United States
AppleMed Research Inc.
Miami, Florida, United States
Radiant Research Inc.
Pinellas Park, Florida, United States
Beacon Clinical
Brockton, Massachusetts, United States
Radiant Research Inc Columbus
Columbus, Ohio, United States
Hillcrest Clinical Research
Olahoma City, Oklahoma, United States
PMG Research of Knoxville
Knoxville, Tennessee, United States
PMG Research of Knoxville
Knoxville, Tennessee, United States
Tekton Research
Austin, Texas, United States
Countries
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Other Identifiers
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01-13
Identifier Type: -
Identifier Source: org_study_id