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Safety and Efficacy Study of Bee Venom to Treat Knee Osteoarthritis

Primary Purpose

Persons With Mild to Moderate Knee Osteoarthritis

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Injecting bee venom as a treatment for OA
Sponsored by
Rheumatology Therapeutics Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persons With Mild to Moderate Knee Osteoarthritis

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kochan Institute for Healing Arts ResearchRecruiting
  • Rheumatology Therapeutics Medical CenterRecruiting

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
November 10, 2005
Last Updated
November 14, 2005
Sponsor
Rheumatology Therapeutics Medical Center
Collaborators
Kochan Institute for Healing Arts Research
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1. Study Identification

Unique Protocol Identification Number
NCT00253942
Brief Title
Safety and Efficacy Study of Bee Venom to Treat Knee Osteoarthritis
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rheumatology Therapeutics Medical Center
Collaborators
Kochan Institute for Healing Arts Research

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persons With Mild to Moderate Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Injecting bee venom as a treatment for OA
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale
Title
Change in Knee Injury and Osteoarthritis Outcome Score
Title
Change in use of analgesic meds after 6 weeks of treatment
Title
Change in 50 ft. walk and 4 step up/down climb time
Secondary Outcome Measure Information:
Title
Adverse event incidence
Title
Baseline and visit 12 laboratory assessments
Title
Change in tenderness and motion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Ratiner, MD
Organizational Affiliation
Medical Director of Rheumatology Therapeutics Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Kochan, MD
Organizational Affiliation
Medical Director of Kochan Institute for Healing Arts Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kochan Institute for Healing Arts Research
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ray Seipel, MA
Phone
818-995-9331
Email
ray@healingartsresearch.org
First Name & Middle Initial & Last Name & Degree
Andrew Kochan, MD
Facility Name
Rheumatology Therapeutics Medical Center
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phil Sheng, BS
Phone
818-996-4077
Ext
217
Email
Phil.Sheng@Gmail.com
First Name & Middle Initial & Last Name & Degree
Boris Ratiner, MD

12. IPD Sharing Statement

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Safety and Efficacy Study of Bee Venom to Treat Knee Osteoarthritis

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