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Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

This study is not yet open for participant recruitment.
Verified April 2013 by Apimeds, Inc.
Sponsor:
Information provided by (Responsible Party):
Apimeds, Inc.
ClinicalTrials.gov Identifier:
NCT01112722
First received: April 25, 2010
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Apimeds, Inc.:

Primary Outcome Measures:
  • relief of pain and inflammation [ Time Frame: over 4 weeks of escalating dose and 12 weeks final treatment dose ] [ Designated as safety issue: Yes ]
    lower to higher doses/injections over treatment period 400 mg in 100 mcg dose with maximum of 1500 mcg in 100 mcg ingections of 0.1 ml


Secondary Outcome Measures:
  • increased range of motion and activity [ Time Frame: during total 16 week treatment period and assessment beyond for 6 weeks ] [ Designated as safety issue: No ]
    WOMAC - VAS


Estimated Enrollment: 330
Study Start Date: August 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112722

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

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: 01-10
Study First Received: April 25, 2010
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration

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 June 17, 2013