Osteoarthritis of the KneePhase 2HBVNCT00949754
Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation
A Phase 2 study testing honeybee venom (Apitoxin (Korea) Apitox (USA)) in people with Osteoarthritis of the Knee, run by Apimeds, Inc. at 4 sites in United States.
Trial summary
The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- honeybee venom (Apitoxin (Korea) Apitox (USA))
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2009to Apr 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Radiant Research - Chicago
Chicago, Illinois, 60657
Radiant Research - Columbus
Columbus, Ohio, 43212
Radiant Research Inc.
Pinellas Park, Florida, 33781
Radiant Research - San Antonio
San Antonio, Texas, 78217
About this study
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
The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- honeybee venom (Apitoxin (Korea) Apitox (USA))
- Keywords
- honeybee venom, osteoarthritis, pain, knees
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
honeybee venom (Apitoxin (Korea) Apitox (USA))Drug
Also called Apitoxin (Korea) Apitox (USA)
multiple intradermal injections of 100 ug pure honeybee venom
| Study group | Role | What they receive |
|---|---|---|
| histamine | Active comparator | histamine in saline administered ID as active control for Apitox Receives: Drug: honeybee venom (Apitoxin (Korea) Apitox (USA)) |
| Apitox pure honeybee venom | Experimental | ID study drug Receives: Drug: honeybee venom (Apitoxin (Korea) Apitox (USA)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apimeds, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christopher MH Kim, M.D., Study chair, Apimeds, CEORobert Brooks, PhD, Study director, Apimeds, Inc, US Chief Operating Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949754
- Sponsor's protocol ID
- API092
- Acronym
- HBV
- Status last verified
- May 2010
- First submitted
- 28 Jul 2009
- Last updated
- 5 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00949754
- Acronym / sponsor ID
- HBV / API092
- Conditions
- Osteoarthritis of the Knee
- Keywords
- honeybee venom, osteoarthritis, pain, knees
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Apimeds, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 30 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| histamine | Active comparator | Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))histamine in saline administered ID as active control for Apitox |
| Apitox pure honeybee venom | Experimental | Drug: honeybee venom (Apitoxin (Korea) Apitox (USA))ID study drug |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| honeybee venom (Apitoxin (Korea) Apitox (USA))Also: Apitoxin (Korea) Apitox (USA)multiple intradermal injections of 100 ug pure honeybee venom | Drug | Apitox pure honeybee venom, histamine |
Primary outcome
WOMAC
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher MH Kim, M.D. study chair
Apimeds, CEO
Robert Brooks, PhD study director
Apimeds, Inc, US Chief Operating Officer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing honeybee venom (Apitoxin (Korea) Apitox (USA)) in people with Osteoarthritis of the Knee, run by Apimeds, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2010.