Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation
HBV
A Multi-Center, Randomized, Double Blind, Active-Controlled, Parallel Group Clinical Study to Evaluate the Dose Effect of Intradermal Injections of Apitox vs. Histamine in Subjects With Osteoarthritis Symptoms of the Knee
1 other identifier
interventional
40
1 country
4
Brief Summary
The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2009
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2009
CompletedFirst Posted
Study publicly available on registry
July 30, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedMay 5, 2010
May 1, 2010
5 months
July 28, 2009
May 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
WOMAC
14 days
Study Arms (2)
histamine
ACTIVE COMPARATORhistamine in saline administered ID as active control for Apitox
Apitox pure honeybee venom
EXPERIMENTALID study drug
Interventions
multiple intradermal injections of 100 ug pure honeybee venom
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Apimeds, Inc.lead
Study Sites (4)
Radiant Research Inc.
Pinellas Park, Florida, 33781, United States
Radiant Research - Chicago
Chicago, Illinois, 60657, United States
Radiant Research - Columbus
Columbus, Ohio, 43212, United States
Radiant Research - San Antonio
San Antonio, Texas, 78217, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christopher MH Kim, M.D.
Apimeds, CEO
- STUDY DIRECTOR
Robert Brooks, PhD
Apimeds, Inc, US Chief Operating Officer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 28, 2009
First Posted
July 30, 2009
Study Start
October 1, 2009
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
May 5, 2010
Record last verified: 2010-05