search
Back to results

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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
honeybee venom (Apitoxin (Korea) Apitox (USA))
Sponsored by
Apimeds, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring honeybee venom, osteoarthritis, pain, knees

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Radiant Research Inc.
  • Radiant Research - Chicago
  • Radiant Research - Columbus
  • Radiant Research - San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

histamine

Apitox pure honeybee venom

Arm Description

histamine in saline administered ID as active control for Apitox

ID study drug

Outcomes

Primary Outcome Measures

WOMAC

Secondary Outcome Measures

Full Information

First Posted
July 28, 2009
Last Updated
May 4, 2010
Sponsor
Apimeds, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00949754
Brief Title
Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation
Acronym
HBV
Official Title
A Multi-Center, Randomized, Double Blind, Active-Controlled, Parallel Group Clinical Study to Evaluate the Dose Effect of Intradermal Injections of Apitox vs. Histamine in Subjects With Osteoarthritis Symptoms of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Apimeds, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
honeybee venom, osteoarthritis, pain, knees

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
histamine
Arm Type
Active Comparator
Arm Description
histamine in saline administered ID as active control for Apitox
Arm Title
Apitox pure honeybee venom
Arm Type
Experimental
Arm Description
ID study drug
Intervention Type
Drug
Intervention Name(s)
honeybee venom (Apitoxin (Korea) Apitox (USA))
Other Intervention Name(s)
Apitoxin (Korea) Apitox (USA)
Intervention Description
multiple intradermal injections of 100 ug pure honeybee venom
Primary Outcome Measure Information:
Title
WOMAC
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher MH Kim, M.D.
Organizational Affiliation
Apimeds, CEO
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Robert Brooks, PhD
Organizational Affiliation
Apimeds, Inc, US Chief Operating Officer
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Radiant Research - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Radiant Research - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Radiant Research - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation

We'll reach out to this number within 24 hrs