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Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Apimeds, Inc.
ClinicalTrials.gov Identifier:
NCT01112722
First received: April 25, 2010
Last updated: December 11, 2016
Last verified: December 2016
  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
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 ]
    WOMAC


Secondary Outcome Measures:
  • PhGA [ Time Frame: from 4 wks global assessment through 12 wks ]
    physcians global assessment

  • PGA [ Time Frame: from 4 wks throught the 12 wk treatment ]
    patients global assessmen


Enrollment: 363
Study Start Date: December 2013
Study Completion Date: December 2016
Primary Completion Date: November 2016 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Alabama
Functional Research LLC
Gulf Shores, Alabama, United States, 36542
United States, Arizona
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 87512
United States, California
SC Clinical Research Inc.
Garden Grove, California, United States, 92844
Axis Clinical Trials
Los Angeles, California, United States, 90036
Westlake Medical Research
Thousand Oaks, California, United States, 91360
SC Clinical Research Inc.
Upland, California, United States, 91786
United States, Florida
Schrock Orthopedics Research
Ft Lauderdale, Florida, United States, 33316
AppleMed Research Inc.
Miami, Florida, United States, 33155
Radiant Research Inc.
Pinellas Park, Florida, United States, 33781
United States, Massachusetts
Beacon Clinical
Brockton, Massachusetts, United States, 02301
United States, Ohio
Radiant Research Inc Columbus
Columbus, Ohio, United States, 43212
United States, Oklahoma
Hillcrest Clinical Research
Olahoma City, Oklahoma, United States, 73119
United States, Tennessee
PMG Research of Knoxville
Knoxville, Tennessee, United States, 37912
PMG Research of Knoxville
Knoxville, Tennessee, United States, 37938
United States, Texas
Tekton Research
Austin, Texas, United States, 78745
Sponsors and Collaborators
Apimeds, Inc.
Investigators
Study Chair: Christopher M. H. Kim, M.D. Apimeds, CEO
  More Information

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: December 11, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

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

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

ClinicalTrials.gov processed this record on February 27, 2017