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Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

NCT01112722 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2016-12-13

No results posted yet for this study

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

Conditions

  • Osteoarthritis of the Knee

Interventions

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

BIOLOGICAL

histamine

imitates pain and erythema of honeybee venom

Sponsors & Collaborators

  • Apimeds, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher M. H. Kim, M.D. · Apimeds, CEO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01112722 on ClinicalTrials.gov