Apitox, Honeybee Venom Treatment for Osteoarthritis Pain... | NCT00949754

Studies
Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation

NCT00949754

Sponsor

Apimeds, Inc.

Status

Completed

Last Update Posted

May 5, 2010Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Osteoarthritis of the Knee

Interventions

honeybee venom (Apitoxin (Korea) Apitox (USA))

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jul 28, 2009

First Submission Date that Met QC Criteria

Jul 29, 2009

First Posted Date

Jul 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2010

Last Update Posted Date

May 5, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
histamine	Active Comparator	histamine in saline administered ID as active control for Apitox	Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))
Apitox pure honeybee venom	Experimental	ID study drug	Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))

Interventions

Name	Type	Description	Arm Group Labels	Other Names
honeybee venom (Apitoxin (Korea) Apitox (USA))	Drug	multiple intradermal injections of 100 ug pure honeybee venom	Apitox pure honeybee venom histamine

Measure	Description	Time Frame
WOMAC		14 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christopher MH Kim, M.D.	Apimeds, CEO	Study Chair
Robert Brooks, PhD	Apimeds, Inc, US Chief Operating Officer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radiant Research Inc.		Pinellas Park	Florida	33781	United States
Radiant Research - Chicago

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis
D010146	Pain

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001514	Bee Venoms

Ancestor Terms

ID	Term
D001180	Arthropod Venoms
D014688	Venoms
D045424	Complex Mixtures
D014118	Toxins, Biological

Browse Leaves

Not provided

Browse Branches

Not provided