Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

Phase 3

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Biological: histamine; Biological: Apitox, purified honeybee toxin, lyophilized in saline

• Registration Number: NCT01112722
• Lead Sponsor: 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

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-04-25
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Study Start: 2013-12
• Primary Completion: 2016-11
• Status Verified: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-11
• Last Update Posted: 2016-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 363

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
histamine injection	histamine	the histamine injection produces a similar local effect of pain and erythema as the active drug
Apitox, purified honeybee toxin, injections	Apitox, purified honeybee toxin, lyophilized in saline	active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline'

Primary Outcome Measures

Name	Time	Method
WOMAC	from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up	WOMAC

Secondary Outcome Measures

Name	Time	Method
PGA	from 4 wks throught the 12 wk treatment	patients global assessmen
PhGA	from 4 wks global assessment through 12 wks	physcians global assessment

Trial Locations

Locations (13)

Functional Research LLC; 🇺🇸 Gulf Shores, Alabama, United States

SC Clinical Research Inc.; 🇺🇸 Upland, California, United States

Axis Clinical Trials; 🇺🇸 Los Angeles, California, United States

Schrock Orthopedics Research; 🇺🇸 Ft Lauderdale, Florida, United States

Westlake Medical Research; 🇺🇸 Thousand Oaks, California, United States

Radiant Research Inc.; 🇺🇸 Pinellas Park, Florida, United States

AppleMed Research Inc.; 🇺🇸 Miami, Florida, United States

Beacon Clinical; 🇺🇸 Brockton, Massachusetts, United States

Hillcrest Clinical Research; 🇺🇸 Olahoma City, Oklahoma, United States

Radiant Research Inc Columbus; 🇺🇸 Columbus, Ohio, United States

Tekton Research; 🇺🇸 Austin, Texas, United States

Tucson Orthopaedic Institute; 🇺🇸 Tucson, Arizona, United States

PMG Research of Knoxville; 🇺🇸 Knoxville, Tennessee, United States