Clinical trial NCT01112722: Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Keywords: honeybee toxin
Apitox
pain
inflammation
osteoarthritis
Apitoxin
Lead sponsor: Apimeds, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 363
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: feasibility and Site selection has been completed in the US and India

Eligibility 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

Primary outcomes:
measure: WOMAC
timeFrame: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up
Secondary outcomes:
measure: PhGA
timeFrame: from 4 wks global assessment through 12 wks
measure: PGA
timeFrame: from 4 wks throught the 12 wk treatment
Other outcomes:
Locations:
city: Gulf Shores
country: United States
facility: Functional Research LLC
state: Alabama
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Garden Grove
country: United States
facility: SC Clinical Research Inc.
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Thousand Oaks
country: United States
facility: Westlake Medical Research
state: California
city: Upland
country: United States
facility: SC Clinical Research Inc.
state: California
city: Ft Lauderdale
country: United States
facility: Schrock Orthopedics Research
state: Florida
city: Miami
country: United States
facility: AppleMed Research Inc.
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research Inc.
state: Florida
city: Brockton
country: United States
facility: Beacon Clinical
state: Massachusetts
city: Columbus
country: United States
facility: Radiant Research Inc Columbus
state: Ohio
city: Olahoma City
country: United States
facility: Hillcrest Clinical Research
state: Oklahoma
city: Knoxville
country: United States
facility: PMG Research of Knoxville
state: Tennessee
city: Knoxville
country: United States
facility: PMG Research of Knoxville
state: Tennessee
city: Austin
country: United States
facility: Tekton Research
state: Texas
Study officials:
affiliation: Apimeds, CEO
name: Christopher M. H. Kim, M.D.
role: STUDY_CHAIR
References: