Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation

A Multi-Center, Randomized, Double Blind, Active-Controlled, Parallel Group Clinical Study to Evaluate the Dose Effect of Intradermal Injections of Apitox vs. Histamine in Subjects With Osteoarthritis Symptoms of the Knee

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00949754

Acronym

HBV

Enrollment

Registered

2009-07-30

Start date

2009-10-31

Completion date

2010-04-30

Last updated

2010-05-05

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 venom, osteoarthritis, pain, knees

Brief summary

The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.

Interventions

DRUGhoneybee venom (Apitoxin (Korea) Apitox (USA))

multiple intradermal injections of 100 ug pure honeybee venom

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 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
WOMAC	14 days

Countries

United States

Outcome results

None listed

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