Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:30 - 85
Updated:4/2/2016
Start Date:December 2013
End Date:December 2015
Contact:Robert Brooks, PhD
Email:dbrooks2@apimeds.com
Phone:610-754-7631

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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

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

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
We found this trial at
15
sites
Austin, Texas 78745
1212
mi
from 91732
Austin, TX
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1275 Olentangy River Road
Columbus, Ohio 43212
614-294-3854
1959
mi
from 91732
Columbus, OH
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6850 Coral Way # 409
Miami, Florida 33155
2316
mi
from 91732
Miami, FL
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Brockton, Massachusetts 02301
2580
mi
from 91732
Brockton, MA
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Ft Lauderdale, Florida 33316
2317
mi
from 91732
Ft Lauderdale, FL
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Garden Grove, California 92844
21
mi
from 91732
Garden Grove, CA
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Gulf Shores, Alabama 36542
1785
mi
from 91732
Gulf Shores, AL
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Knoxville, Tennessee 37912
1923
mi
from 91732
Knoxville, TN
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Knoxville, Tennessee 37912
1923
mi
from 91732
Knoxville, TN
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Los Angeles, California 90036
19
mi
from 91732
Los Angeles, CA
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Olahoma City, Oklahoma 73119
1162
mi
from 91732
Olahoma City, OK
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Pinellas Park, Florida 33781
2124
mi
from 91732
Pinellas Park, FL
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Thousand Oaks, California 91360
49
mi
from 91732
Thousand Oaks, CA
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Tucson, Arizona 85713
427
mi
from 91732
Tucson, AZ
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Upland, California 91786
21
mi
from 91732
Upland, CA
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