Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation (HBV)

This study has been completed.
Sponsor:
Information provided by:
Apimeds, Inc.
ClinicalTrials.gov Identifier:
NCT00949754
First received: July 28, 2009
Last updated: May 4, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Apimeds, Inc.:

Primary Outcome Measures:
  • WOMAC [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: histamine
histamine in saline administered ID as active control for Apitox
Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))
multiple intradermal injections of 100 ug pure honeybee venom
Other Name: Apitoxin (Korea) Apitox (USA)
Experimental: Apitox pure honeybee venom
ID study drug
Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))
multiple intradermal injections of 100 ug pure honeybee venom
Other Name: Apitoxin (Korea) Apitox (USA)

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949754

Locations
United States, Florida
Radiant Research Inc.
Pinellas Park, Florida, United States, 33781
United States, Illinois
Radiant Research - Chicago
Chicago, Illinois, United States, 60657
United States, Ohio
Radiant Research - Columbus
Columbus, Ohio, United States, 43212
United States, Texas
Radiant Research - San Antonio
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Apimeds, Inc.
Investigators
Study Chair: Christopher MH Kim, M.D. Apimeds, CEO
Study Director: Robert Brooks, PhD Apimeds, Inc, US Chief Operating Officer
  More Information

No publications provided

Responsible Party: Robert Brooks PhD, Chief Operating Officer US, Apimeds, Inc.
ClinicalTrials.gov Identifier: NCT00949754     History of Changes
Other Study ID Numbers: API092
Study First Received: July 28, 2009
Last Updated: May 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Apimeds, Inc.:
honeybee venom
osteoarthritis
pain
knees

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Histamine
Histamine Agents
Histamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014