Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

NCT01112722

Osteoarthritis of the Knee

COMPLETED PHASE3

A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain

NCT02184156

Osteoarthritis of the Knee

COMPLETED PHASE1/PHASE2

A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

NCT02556710

Osteoarthritis of the Knee

COMPLETED PHASE3

AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

NCT03182686

Osteoarthritis, Knee Knee Osteoarthritis Knee Arthritis +1 more

COMPLETED PHASE3

Study to Evaluate Safety/Efficacy of a Single Preop Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery

NCT02807428

Post-surgical Pain

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis of the Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

histamine

histamine in saline administered ID as active control for Apitox

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

multiple intradermal injections of 100 ug pure honeybee venom

Apitox pure honeybee venom

ID study drug

Group Type EXPERIMENTAL

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

Intervention Type DRUG

multiple intradermal injections of 100 ug pure honeybee venom

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

multiple intradermal injections of 100 ug pure honeybee venom

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Apitoxin (Korea) Apitox (USA)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No