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Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Apitox, purified honeybee toxin, lyophilized in saline
histamine
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 toxin, Apitox, pain, inflammation, osteoarthritis, Apitoxin

Eligibility Criteria

30 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

  • Functional Research LLC
  • Tucson Orthopaedic Institute
  • SC Clinical Research Inc.
  • Axis Clinical Trials
  • Westlake Medical Research
  • SC Clinical Research Inc.
  • Schrock Orthopedics Research
  • AppleMed Research Inc.
  • Radiant Research Inc.
  • Beacon Clinical
  • Radiant Research Inc Columbus
  • Hillcrest Clinical Research
  • PMG Research of Knoxville
  • PMG Research of Knoxville
  • Tekton Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Apitox, purified honeybee toxin, injections

histamine injection

Arm Description

active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline'

the histamine injection produces a similar local effect of pain and erythema as the active drug

Outcomes

Primary Outcome Measures

WOMAC
WOMAC

Secondary Outcome Measures

PhGA
physcians global assessment
PGA
patients global assessmen

Full Information

First Posted
April 25, 2010
Last Updated
December 11, 2016
Sponsor
Apimeds, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01112722
Brief Title
Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis
Official Title
A Multicenter, Randomized, Double Blind, Active Controlled, Parallel Group, Clinical Study, to Evaluate the Safety and Efficacy of Apitox vs Histamine in Subjects With Refractory Osteoarthritis Pain and Inflammation of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apimeds, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global Assessments and primary efficacy measure of relief of pain and inflammation over a 12 week treatment period after randomization into the trial. Secondary efficacy is improvement of mobility Treatment effect will be compared in a 2-1 Apitox vs active control
Detailed Description
feasibility and Site selection has been completed in the US and India

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 toxin, Apitox, pain, inflammation, osteoarthritis, Apitoxin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
363 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apitox, purified honeybee toxin, injections
Arm Type
Active Comparator
Arm Description
active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline'
Arm Title
histamine injection
Arm Type
Placebo Comparator
Arm Description
the histamine injection produces a similar local effect of pain and erythema as the active drug
Intervention Type
Biological
Intervention Name(s)
Apitox, purified honeybee toxin, lyophilized in saline
Other Intervention Name(s)
Apitoxin in Korea
Intervention Description
intradermal injections of 0.1mg apitox in 0.1ml WFI over 12 weeks treatment period, injections twice weekly range from 1 to 20 injections
Intervention Type
Biological
Intervention Name(s)
histamine
Intervention Description
imitates pain and erythema of honeybee venom
Primary Outcome Measure Information:
Title
WOMAC
Description
WOMAC
Time Frame
from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up
Secondary Outcome Measure Information:
Title
PhGA
Description
physcians global assessment
Time Frame
from 4 wks global assessment through 12 wks
Title
PGA
Description
patients global assessmen
Time Frame
from 4 wks throught the 12 wk treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 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 M. H. Kim, M.D.
Organizational Affiliation
Apimeds, CEO
Official's Role
Study Chair
Facility Information:
Facility Name
Functional Research LLC
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
Country
United States
Facility Name
Tucson Orthopaedic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
87512
Country
United States
Facility Name
SC Clinical Research Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Westlake Medical Research
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
SC Clinical Research Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Schrock Orthopedics Research
City
Ft Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
AppleMed Research Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Radiant Research Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Beacon Clinical
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Radiant Research Inc Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Hillcrest Clinical Research
City
Olahoma City
State/Province
Oklahoma
ZIP/Postal Code
73119
Country
United States
Facility Name
PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
PMG Research of Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

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