Safety and Efficacy Study of Bee Venom to Treat Knee Osteoarthritis

November 14, 2005 updated by: Rheumatology Therapeutics Medical Center

A Randomized, Double-Blind, Histamine-Controlled, Phase 3 Study to Determine the Safety and Efficacy of Bee Venom in the Treatment of Knee Osteoarthritis

Study wishes to determine if the use of injectable bee venom is a safe and effective treatment for persons with mild to moderate knee Osteoarthritis and would result in decreased report of pain and discomfort, increased function during daily activities, decrease use of analgesic meds, and improvement in walking and climbing steps. We will be using histamine as a control. 40 subjects will be enrolled in a 3:1 allocation ratio between bee venom and histamine. Each injection of bee venom dosage will consist of 100 micrograms of dried bee venom in 0.1 ml. of 0.5% preservative free Xylocaine. The histamine dosage will consist of .0025 milligrams of histamine in 0.5% preservative free Xylocaine. Subjects will visit the study center for 14 visits over an 18 week span. The clinical hypothesis is that bee venom is an effective treatment for Osteoarthritis and will reduce pain and discomfort, increase range of motion, increase daily function, decrease walking and stair climbing time, and decrease the need of analgesic medication for a period of time beyond treatment (after the study has concluded.) The clinical safety hypothesis is that for persons not allergic to bee venom (patients allergic will not be allowed to enter into the study) the side effects will be small. The most common side effects for bee venom and histamine will be redness and itchiness which will be tolerable and safe.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encino, California, United States, 91316
        • Recruiting
        • Kochan Institute for Healing Arts Research
        • Contact:
        • Principal Investigator:
          • Andrew Kochan, MD
      • Tarzana, California, United States, 91356
        • Recruiting
        • Rheumatology Therapeutics Medical Center
        • Contact:
        • Principal Investigator:
          • Boris Ratiner, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet clinical criteria for Osteoarthritis in one knee
  • Morning stiffness less than 30 minutes duration
  • VAS pain level of 4 to 8 on a 0 to 10 scale when walking
  • Older than 35 years of age
  • On a stable dose of medication or none at all due to intolerance
  • Ability to tolerate Acetaminophen as their only pain medication for the entire study
  • Ability to read, understand, and give informed consent and sign the informed consent form

Exclusion Criteria:

  • Allergy to bee venom or histamine
  • Allergy to Lidocaine
  • Any type of inflammatory arthritis such as RA, SLE, Psoriatic
  • Fibromyalgia or any pain problem that requires the use of pain medication or anti-inflammatory
  • Depression or any condition that interferes with memory or critical analysis
  • History of prolotherapy, bee venom therapy, or injection of hyaluronic acid or cortisone within the last 3 months
  • Osteoarthritis of the hip, ankle, or any condition that interferes with walking 50 ft. or up and down stairs
  • Elevated CRP, SED rate
  • Recent injury to the knee which is causing pain or functional problems
  • Any previous invasive procedure on the study knee
  • Inability to understand the informed consent form or refusal to sign it
  • Cardiac disease interfering with ability to get epinephrine
  • VAS pain level greater than 8 on a 0 to 10 scale when walking
  • Inability to stop anti-inflammatory medication for the entire study and use only Acetaminophen
  • Taking beta blockers
  • Taking chronic anti-histamines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in Visual Analog Scale
Change in Knee Injury and Osteoarthritis Outcome Score
Change in use of analgesic meds after 6 weeks of treatment
Change in 50 ft. walk and 4 step up/down climb time

Secondary Outcome Measures

Outcome Measure
Adverse event incidence
Baseline and visit 12 laboratory assessments
Change in tenderness and motion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rheumatology Therapeutics Medical Center

Collaborators

Kochan Institute for Healing Arts Research

Investigators

  • Principal Investigator: Boris Ratiner, MD, Medical Director of Rheumatology Therapeutics Medical Center
  • Principal Investigator: Andrew Kochan, MD, Medical Director of Kochan Institute for Healing Arts Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Registration Dates

First Submitted

November 10, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 15, 2005

Study Record Updates

Last Update Posted (Estimate)

November 15, 2005

Last Update Submitted That Met QC Criteria

November 14, 2005

Last Verified

October 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OABVTKNEE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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