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Completed

NCT Number: NCT01112722

Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

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

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Inflammation Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Functional Research LLC, Gulf Shores, Alabama, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apitox, purified honeybee toxin, lyophilized in saline

Biological

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

histamine

Biological

imitates pain and erythema of honeybee venom

Primary outcomes

  1. WOMAC

    Time frame: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up

    WOMAC

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Apimeds, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2010
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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