Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis

NCT01112722 | Completed Phase 3 DMC

• 1 other identifier: 01-13
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 15

Brief 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

Keywords

honeybee toxin; Apitox; pain; inflammation; osteoarthritis; Apitoxin

Outcome Measures

Primary Outcomes (1)

• WOMAC

  WOMAC

  from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up

Secondary Outcomes (2)

• PhGA

  from 4 wks global assessment through 12 wks

• PGA

  from 4 wks throught the 12 wk treatment

Study Arms (2)

Apitox, purified honeybee toxin, injections

ACTIVE COMPARATOR

active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline'

Biological: Apitox, purified honeybee toxin, lyophilized in saline

histamine injection

PLACEBO COMPARATOR

the histamine injection produces a similar local effect of pain and erythema as the active drug

Biological: histamine

Interventions

Apitox, purified honeybee toxin, lyophilized in saline BIOLOGICAL

intradermal injections of 0.1mg apitox in 0.1ml WFI over 12 weeks treatment period, injections twice weekly range from 1 to 20 injections

Also known as: Apitoxin in Korea

Apitox, purified honeybee toxin, injections

histamine BIOLOGICAL

imitates pain and erythema of honeybee venom

histamine injection

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Apimeds, Inc.: lead

Study Sites (15)

Functional Research LLC

Gulf Shores, Alabama, 36542, United States

Location

Tucson Orthopaedic Institute

Tucson, Arizona, 87512, United States

Location

SC Clinical Research Inc.

Garden Grove, California, 92844, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

Westlake Medical Research

Thousand Oaks, California, 91360, United States

Location

SC Clinical Research Inc.

Upland, California, 91786, United States

Location

Schrock Orthopedics Research

Fort Lauderdale, Florida, 33316, United States

Location

AppleMed Research Inc.

Miami, Florida, 33155, United States

Location

Radiant Research Inc.

Pinellas Park, Florida, 33781, United States

Location

Beacon Clinical

Brockton, Massachusetts, 02301, United States

Location

Radiant Research Inc Columbus

Columbus, Ohio, 43212, United States

Location

Hillcrest Clinical Research

Olahoma City, Oklahoma, 73119, United States

Location

PMG Research of Knoxville

Knoxville, Tennessee, 37912, United States

Location

PMG Research of Knoxville

Knoxville, Tennessee, 37938, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Inflammation; Osteoarthritis

Interventions

Sodium Chloride; Bee Venoms; Histamine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Arthropod Venoms; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators

Study Officials

• Christopher M. H. Kim, M.D.

  Apimeds, CEO

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2010
• First Posted: April 28, 2010
• Study Start: December 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 13, 2016

Record last verified: 2016-12

Locations

US (15)