Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

Completed · Phase 3

Conditions studied: Osteoarthritis of the Knee

In brief

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

Key facts

Study ID

NCT01112722

Run by

Apimeds, Inc.

People needed

363

Starts

2013-12-01

Expected to finish

2016-12-01

Last updated by the study team

2016-12-13

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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