Persons With Mild to Moderate Knee OsteoarthritisPhase 3NCT00253942
Safety and Efficacy Study of Bee Venom to Treat Knee Osteoarthritis
A Phase 3 study testing Injecting bee venom as a treatment for OA in people with Persons With Mild to Moderate Knee Osteoarthritis, run by Rheumatology Therapeutics Medical Center at 2 sites in United States.
Trial summary
Study wishes to determine if the use of injectable bee venom is a safe and effective treatment for persons with mild to moderate knee Osteoarthritis and would result in decreased report of pain and discomfort, increased function during daily activities, decrease use of analgesic meds, and improvement in walking and… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Persons With Mild to Moderate Knee Osteoarthritis
- What is being tested?
- Injecting bee venom as a treatment for OA
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2005to not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meet clinical criteria for Osteoarthritis in one knee
- Morning stiffness less than 30 minutes duration
- VAS pain level of 4 to 8 on a 0 to 10 scale when walking
- Older than 35 years of age
- On a stable dose of medication or none at all due to intolerance
- Ability to tolerate Acetaminophen as their only pain medication for the entire study
- Ability to read, understand, and give informed consent and sign the informed consent form
Who cannot join
- Allergy to bee venom or histamine
- Allergy to Lidocaine
- Any type of inflammatory arthritis such as RA, SLE, Psoriatic
- Fibromyalgia or any pain problem that requires the use of pain medication or anti-inflammatory
- Depression or any condition that interferes with memory or critical analysis
- History of prolotherapy, bee venom therapy, or injection of hyaluronic acid or cortisone within the last 3 months
Show all 16Show fewer
- Osteoarthritis of the hip, ankle, or any condition that interferes with walking 50 ft. or up and down stairs
- Elevated CRP, SED rate
- Recent injury to the knee which is causing pain or functional problems
- Any previous invasive procedure on the study knee
- Inability to understand the informed consent form or refusal to sign it
- Cardiac disease interfering with ability to get epinephrine
- VAS pain level greater than 8 on a 0 to 10 scale when walking
- Inability to stop anti-inflammatory medication for the entire study and use only Acetaminophen
- Taking beta blockers
- Taking chronic anti-histamines
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Kochan Institute for Healing Arts Research
Encino, California, 91316
Ray Seipel, MA, 818-995-9331, ray@healingartsresearch.org
Andrew Kochan, MD
- Recruiting
Rheumatology Therapeutics Medical Center
Tarzana, California, 91356
Phil Sheng, BS, 818-996-4077 ext. 217, Phil.Sheng@Gmail.com
Boris Ratiner, MD
About this study
Official title: A Randomized, Double-Blind, Histamine-Controlled, Phase 3 Study to Determine the Safety and Efficacy of Bee Venom in the Treatment of Knee Osteoarthritis
Study wishes to determine if the use of injectable bee venom is a safe and effective treatment for persons with mild to moderate knee Osteoarthritis and would result in decreased report of pain and discomfort, increased function during daily activities, decrease use of analgesic meds, and improvement in walking and climbing steps. We will be using histamine as a control. 40 subjects will be enrolled in a 3:1 allocation ratio between bee venom and histamine. Each injection of bee venom dosage will consist of 100 micrograms of dried bee venom in 0.1 ml. of 0.5% preservative free Xylocaine. The histamine dosage will consist of .0025 milligrams of histamine in 0.5% preservative free Xylocaine. Subjects will visit the study center for 14 visits over an 18 week span. The clinical hypothesis is that bee venom is an effective treatment for Osteoarthritis and will reduce pain and discomfort, increase range of motion, increase daily function, decrease walking and stair climbing time, and decrease the need of analgesic medication for a period of time beyond treatment (after the study has concluded.) The clinical safety hypothesis is that for persons not allergic to bee venom (patients allergic will not be allowed to enter into the study) the side effects will be small. The most common side effects for bee venom and histamine will be redness and itchiness which will be tolerable and safe.
- Being tested
- Injecting bee venom as a treatment for OA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injecting bee venom as a treatment for OAProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale
Change in Knee Injury and Osteoarthritis Outcome Score
Change in use of analgesic meds after 6 weeks of treatment
Change in 50 ft. walk and 4 step up/down climb time
Secondary outcomes (3)
Adverse event incidence
Baseline and visit 12 laboratory assessments
Change in tenderness and motion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persons With Mild to Moderate Knee OsteoarthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Rheumatology Therapeutics Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kochan Institute for Healing Arts Research
- Investigators
- Boris Ratiner, MD, Principal investigator, Medical Director of Rheumatology Therapeutics Medical CenterAndrew Kochan, MD, Principal investigator, Medical Director of Kochan Institute for Healing Arts Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253942
- Sponsor's protocol ID
- OABVTKNEE-001
- Status last verified
- Oct 2005
- First submitted
- 10 Nov 2005
- Last updated
- 15 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Histamine-Controlled, Phase 3 Study to Determine the Safety and Efficacy of Bee Venom in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00253942
- Acronym / sponsor ID
- OABVTKNEE-001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Rheumatology Therapeutics Medical CenterUniversity, hospital or other
- Collaborators
- Kochan Institute for Healing Arts Research
- Study start
- Nov 2005
- First posted
- 15 Nov 2005 (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.
Study wishes to determine if the use of injectable bee venom is a safe and effective treatment for persons with mild to moderate knee Osteoarthritis and would result in decreased report of pain and discomfort, increased function during daily activities, decrease use of analgesic meds, and improvement in walking and climbing steps. We will be using histamine as a control. 40 subjects will be enrolled in a 3:1 allocation ratio between bee venom and histamine. Each injection of bee venom dosage will consist of 100 micrograms of dried bee venom in 0.1 ml. of 0.5% preservative free Xylocaine. The histamine dosage will consist of .0025 milligrams of histamine in 0.5% preservative free Xylocaine. Subjects will visit the study center for 14 visits over an 18 week span. The clinical hypothesis is that bee venom is an effective treatment for Osteoarthritis and will reduce pain and discomfort, increase range of motion, increase daily function, decrease walking and stair climbing time, and decrease the need of analgesic medication for a period of time beyond treatment (after the study has concluded.) The clinical safety hypothesis is that for persons not allergic to bee venom (patients allergic will not be allowed to enter into the study) the side effects will be small. The most common side effects for bee venom and histamine will be redness and itchiness which will be tolerable and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meet clinical criteria for Osteoarthritis in one knee
- Morning stiffness less than 30 minutes duration
- VAS pain level of 4 to 8 on a 0 to 10 scale when walking
- Older than 35 years of age
- On a stable dose of medication or none at all due to intolerance
Key exclusion criteria (16 listed)
- Allergy to bee venom or histamine
- Allergy to Lidocaine
- Any type of inflammatory arthritis such as RA, SLE, Psoriatic
- Fibromyalgia or any pain problem that requires the use of pain medication or anti-inflammatory
- Depression or any condition that interferes with memory or critical analysis
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 |
|---|---|---|
| Injecting bee venom as a treatment for OA | Procedure or surgery | – |
Primary outcome
Change in Visual Analog Scale
Change in Knee Injury and Osteoarthritis Outcome Score
Change in use of analgesic meds after 6 weeks of treatment
Change in 50 ft. walk and 4 step up/down climb time
3 secondary outcomes
Adverse event incidence
Baseline and visit 12 laboratory assessments
Change in tenderness and motion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2005.
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.
Kochan Institute for Healing Arts Research
Encino, United States
Rheumatology Therapeutics Medical Center
Tarzana, United States
Boris Ratiner, MD principal investigator
Medical Director of Rheumatology Therapeutics Medical Center
Andrew Kochan, MD principal investigator
Medical Director of Kochan Institute for Healing Arts Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Injecting bee venom as a treatment for OA in people with Persons With Mild to Moderate Knee Osteoarthritis, run by Rheumatology Therapeutics Medical Center at 2 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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 15 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale. The study lists 4 primary outcomes in all. 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 15 Nov 2005.