Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01112722

Enrollment

363

Registered

2010-04-28

Start date

2013-12-31

Completion date

2016-12-31

Last updated

2016-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Keywords

honeybee toxin, Apitox, pain, inflammation, osteoarthritis, Apitoxin

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

Interventions

BIOLOGICALApitox, 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

BIOLOGICALhistamine

imitates pain and erythema of honeybee venom

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
WOMAC	from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up	WOMAC

Secondary

Measure	Time frame	Description
PhGA	from 4 wks global assessment through 12 wks	physcians global assessment
PGA	from 4 wks throught the 12 wk treatment	patients global assessmen

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026