Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

Osteoarthritis of the Knee Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112722
• Other study ID #: 01-13
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2010
• Last updated: December 11, 2016
• Start date: December 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Apimeds, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Biological:
• 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

Locations

Country	Name	City	State
United States	Tekton Research	Austin	Texas
United States	Beacon Clinical	Brockton	Massachusetts
United States	Radiant Research Inc Columbus	Columbus	Ohio
United States	Schrock Orthopedics Research	Ft Lauderdale	Florida
United States	SC Clinical Research Inc.	Garden Grove	California
United States	Functional Research LLC	Gulf Shores	Alabama
United States	PMG Research of Knoxville	Knoxville	Tennessee
United States	PMG Research of Knoxville	Knoxville	Tennessee
United States	Axis Clinical Trials	Los Angeles	California
United States	AppleMed Research Inc.	Miami	Florida
United States	Hillcrest Clinical Research	Olahoma City	Oklahoma
United States	Radiant Research Inc.	Pinellas Park	Florida
United States	Westlake Medical Research	Thousand Oaks	California
United States	Tucson Orthopaedic Institute	Tucson	Arizona
United States	SC Clinical Research Inc.	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Apimeds, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC	WOMAC	from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up	No
Secondary	PhGA	physcians global assessment	from 4 wks global assessment through 12 wks	No
Secondary	PGA	patients global assessmen	from 4 wks throught the 12 wk treatment	No