Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation (HBV)

Apimeds

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis of the Knee

Treatments: Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))

Study type: Interventional

Funder types: Industry

Identifiers

NCT00949754

API092

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

histamine

Active Comparator group

Description:

histamine in saline administered ID as active control for Apitox

Treatment:

Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))

Apitox pure honeybee venom

Experimental group

Description:

ID study drug

Treatment:

Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))