Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Apimeds, Inc.
Sponsor:
Information provided by (Responsible Party):
Apimeds, Inc.
ClinicalTrials.gov Identifier:
NCT01112722
First received: April 25, 2010
Last updated: March 30, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Osteoarthritis of the Knee
Biological: Apitox, purified honeybee toxin, lyophilized in saline
Biological: histamine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Apimeds, Inc.:

Primary Outcome Measures:
  • WOMAC [ Time Frame: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up ] [ Designated as safety issue: No ]
    WOMAC


Secondary Outcome Measures:
  • PhGA [ Time Frame: from 4 wks global assessment through 12 wks ] [ Designated as safety issue: No ]
    physcians global assessment

  • PGA [ Time Frame: from 4 wks throught the 12 wk treatment ] [ Designated as safety issue: No ]
    patients global assessmen


Estimated Enrollment: 330
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Apitox, purified honeybee toxin, injections
active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline'
Biological: Apitox, purified honeybee toxin, lyophilized in saline
intradermal injections of 0.1mg apitox in 0.1ml WFI over 12 weeks treatment period, injections twice weekly range from 1 to 20 injections
Other Name: Apitoxin in Korea
Placebo Comparator: histamine injection
the histamine injection produces a similar local effect of pain and erythema as the active drug
Biological: histamine
imitates pain and erythema of honeybee venom

Detailed Description:

feasibility and Site selection has been completed in the US and India

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112722

Contacts
Contact: Robert Brooks, PhD 610-754-7631 dbrooks@apimeds.com

Locations
United States, Alabama
Functional Research LLC Recruiting
Gulf Shores, Alabama, United States, 36542
Contact: Deborah Funk    251-967-5214      
Principal Investigator: Gregory S Funk, DO         
United States, Arizona
Tucson Orthopaedic Institute Recruiting
Tucson, Arizona, United States, 87512
Contact: Nebojosa Skrepnik, MD    530-784-6140      
Principal Investigator: Nebojosa Skrepnik, MD         
United States, California
SC Clinical Research Inc. Recruiting
Garden Grove, California, United States, 92844
Contact: Tuan Nguyen    714-364-1472      
Principal Investigator: Michael Dao, MD         
Axis Clinical Trials Recruiting
Los Angeles, California, United States, 90036
Contact: Lydie Hazan, MD    310-289-8242      
Principal Investigator: Lydie Hazan, MD         
Westlake Medical Research Recruiting
Thousand Oaks, California, United States, 91360
Contact: Robert Anderson    805-496-3322      
Principal Investigator: Shariar Cohen-Gadol, MD         
SC Clinical Research Inc. Recruiting
Upland, California, United States, 91786
Contact: Sarah Jordan    909-981-5321      
Principal Investigator: Ghassan E Hadi, MD         
United States, Florida
Schrock Orthopedics Research Recruiting
Ft Lauderdale, Florida, United States, 33316
Contact: Kevin Schrock, MD    954-626-3743      
Principal Investigator: Kevin Shrock, MD         
AppleMed Research Inc. Recruiting
Miami, Florida, United States, 33155
Contact: Carlos Manzano    305-667-8432      
Principal Investigator: Augstin Latorre, MD         
Radiant Research Inc. Recruiting
Pinellas Park, Florida, United States, 33781
Contact: Linda Murray, MD    727-544-6367      
Contact: Carole Taylor    727-544-6367      
Principal Investigator: Linda Murray, MD         
United States, Massachusetts
Beacon Clinical Recruiting
Brockton, Massachusetts, United States, 02301
Contact: Raymond Nomizu    774-462-6606      
Principal Investigator: Kuohung Victoria, MD         
United States, Ohio
Radiant Research Inc Columbus Recruiting
Columbus, Ohio, United States, 43212
Contact: Jim Saunders    614-294-3854      
Principal Investigator: Douglas R Schumacher, MD         
United States, Oklahoma
Hillcrest Clinical Research Recruiting
Olahoma City, Oklahoma, United States, 73119
Contact: Vicki J Conrad, MD    405-208-8989    vconrad@hcrokc.com   
Contact: Fred B Oldham, MD    405-208-8990    foldham@hcrokc.com   
United States, Tennessee
PMG Research of Knoxville Recruiting
Knoxville, Tennessee, United States, 37938
Contact: Kelly Davis    865-244-4276      
Principal Investigator: Rickey Manning, MD         
PMG Research of Knoxville Recruiting
Knoxville, Tennessee, United States, 37912
Contact: Paul H Wakefield, MD    865-244-4276      
United States, Texas
Tekton Research Recruiting
Austin, Texas, United States, 78745
Contact: Jason Roth    512-797-0030      
Principal Investigator: Gregg Lucksinger, MD         
Sponsors and Collaborators
Apimeds, Inc.
Investigators
Study Chair: Christopher M. H. Kim, M.D. Apimeds, CEO
  More Information

No publications provided

Responsible Party: Apimeds, Inc.
ClinicalTrials.gov Identifier: NCT01112722     History of Changes
Other Study ID Numbers: 01-13
Study First Received: April 25, 2010
Last Updated: March 30, 2014
Health Authority: United States: Food and Drug Administration
India: Ministry of Health

Keywords provided by Apimeds, Inc.:
honeybee toxin
Apitox
pain
inflammation
osteoarthritis
Apitoxin

Additional relevant MeSH terms:
Inflammation
Osteoarthritis
Osteoarthritis, Knee
Pathologic Processes
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014