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Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01112722
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Apimeds, Inc.

April 25, 2010
April 28, 2010
December 13, 2016
December 2013
November 2016   (Final data collection date for primary outcome measure)
WOMAC [ Time Frame: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up ]
WOMAC
relief of pain and inflammation [ Time Frame: over 6 weeks of escalating treatment ]
lower to higher doses/injections over treatment period
Complete list of historical versions of study NCT01112722 on ClinicalTrials.gov Archive Site
  • 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
increased range of motion and activity [ Time Frame: during 6 week treatment period and assessment beyond ]
WOMAC
Not Provided
Not Provided
 
Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis
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
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
feasibility and Site selection has been completed in the US and India
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • 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
  • Biological: histamine
    imitates pain and erythema of honeybee venom
  • Active Comparator: Apitox, purified honeybee toxin, injections
    active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline'
    Intervention: Biological: Apitox, purified honeybee toxin, lyophilized in saline
  • Placebo Comparator: histamine injection
    the histamine injection produces a similar local effect of pain and erythema as the active drug
    Intervention: Biological: histamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
363
300
December 2016
November 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 85 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01112722
01-13
Yes
Not Provided
Plan to Share IPD: Undecided
Apimeds, Inc.
Apimeds, Inc.
Not Provided
Study Chair: Christopher M. H. Kim, M.D. Apimeds, CEO
Apimeds, Inc.
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP