Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation - Full Text View

Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation (HBV)

This study is not yet open for participant recruitment.

Verified by Apimeds, Inc., July 2009

First Received: July 28, 2009 Last Updated: August 11, 2009 History of Changes

Sponsored by:	Apimeds, Inc.
Information provided by:	Apimeds, Inc.
ClinicalTrials.gov Identifier:	NCT00949754

Purpose

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

Condition	Intervention	Phase
Osteoarthritis of the Knee	Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase IIa Multi-Center, Randomized, Double Blind, Active and Placebo Controlled, Prospective Clinical Study to Evaluate Doses, Dose Schedule, Treatment Magnitude, Effect & Duration of Effect of Intradermal Injections of Apitox vs. Histamine and Saline Placebo in Patients With Osteoarthritis Symptoms in One or Two Knees With Minimal or no Joint Pain of Fingers and Hips

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Further study details as provided by Apimeds, Inc.:

Primary Outcome Measures:

Estimated Enrollment:	40
Study Start Date:	August 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

multiple intradermal injections of 100 ug pure honeybee venom

Eligibility

Criteria

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:

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Apimeds, Inc. ( Robert Brooks PhD, Chief Operating Officer US )
Study ID Numbers:	API092
Study First Received:	July 28, 2009
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00949754 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Apimeds, Inc.:

honeybee venom
osteoarthritis
pain
knees

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Histamine phosphate

Pain
Rheumatic Diseases
Arthralgia
Histamine
Inflammation

Additional relevant MeSH terms:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 11, 2009