Osteoarthritis of the KneePhase 3NCT01112722
Apitox, Honeybee Toxin for Pain and Inflammation of Osteoarthritis
A Phase 3 study testing Apitox, purified honeybee toxin, lyophilized in saline and histamine in people with Osteoarthritis of the Knee, run by Apimeds, Inc. at 15 sites in United States.
Trial summary
The study will identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global Assessments and primary efficacy measure… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Apitox, purified honeybee toxin, lyophilized in saline and histamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 363 participants
- Where
- 15 sitesUnited States
- Study dates
- Dec 2013to Dec 2016
- 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 30 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
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Tekton Research
Austin, Texas, 78745
Beacon Clinical
Brockton, Massachusetts, 02301
Radiant Research Inc Columbus
Columbus, Ohio, 43212
Schrock Orthopedics Research
Fort Lauderdale, Florida, 33316
SC Clinical Research Inc.
Garden Grove, California, 92844
Functional Research LLC
Gulf Shores, Alabama, 36542
PMG Research of Knoxville
Knoxville, Tennessee, 37912
PMG Research of Knoxville
Knoxville, Tennessee, 37938
Axis Clinical Trials
Los Angeles, California, 90036
AppleMed Research Inc.
Miami, Florida, 33155
Hillcrest Clinical Research
Olahoma City, Oklahoma, 73119
Radiant Research Inc.
Pinellas Park, Florida, 33781
Westlake Medical Research
Thousand Oaks, California, 91360
Tucson Orthopaedic Institute
Tucson, Arizona, 87512
SC Clinical Research Inc.
Upland, California, 91786
About this study
Official title: A Multicenter, Randomized, Double Blind, Active Controlled, Parallel Group, Clinical Study, to Evaluate the Safety and Efficacy of Apitox vs Histamine in Subjects With Refractory Osteoarthritis Pain and Inflammation of the Knee
The study will identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global Assessments and primary efficacy measure of relief of pain and inflammation over a 12 week treatment period after randomization into the trial. Secondary efficacy is improvement of mobility Treatment effect will be compared in a 2-1 Apitox vs active control
Read the detailed description
feasibility and Site selection has been completed in the US and India
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Apitox, purified honeybee toxin, lyophilized in saline, histamine
- Keywords
- honeybee toxin, Apitox, pain, inflammation, osteoarthritis, Apitoxin
- Medical subject headings
- Osteoarthritis, Knee, Pain, Inflammation, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apitox, purified honeybee toxin, lyophilized in salineBiological
Also called Apitoxin in Korea
intradermal injections of 0.1mg apitox in 0.1ml WFI over 12 weeks treatment period, injections twice weekly range from 1 to 20 injections
histamineBiological
imitates pain and erythema of honeybee venom
| Study group | Role | What they receive |
|---|---|---|
| Apitox, purified honeybee toxin, injections | Active comparator | active treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline' Receives: Biological: Apitox, purified honeybee toxin, lyophilized in saline |
| histamine injection | Placebo comparator | the histamine injection produces a similar local effect of pain and erythema as the active drug Receives: Biological: histamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
WOMAC
Measured: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up
Secondary outcomes (2)
PhGA
physcians global assessment
Measured: from 4 wks global assessment through 12 wks
PGA
patients global assessmen
Measured: from 4 wks throught the 12 wk treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startDec 2013
- Primary completionNov 2016
- Study completionDec 2016
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apimeds, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher M. H. Kim, M.D., Study chair, Apimeds, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112722
- Sponsor's protocol ID
- 01-13
- Status last verified
- Dec 2016
- First submitted
- 25 Apr 2010
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Active Controlled, Parallel Group, Clinical Study, to Evaluate the Safety and Efficacy of Apitox vs Histamine in Subjects With Refractory Osteoarthritis Pain and Inflammation of the Knee
- ClinicalTrials.gov ID
- NCT01112722
- Acronym / sponsor ID
- 01-13
- Conditions
- Osteoarthritis of the Knee
- Keywords
- honeybee toxin, Apitox, pain, inflammation, osteoarthritis, Apitoxin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Apimeds, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Apr 2010 (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 identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global Assessments and primary efficacy measure of relief of pain and inflammation over a 12 week treatment period after randomization into the trial. Secondary efficacy is improvement of mobility Treatment effect will be compared in a 2-1 Apitox vs active control
Detailed description
feasibility and Site selection has been completed in the US and India
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apitox, purified honeybee toxin, injections | Active comparator | Biological: Apitox, purified honeybee toxin, lyophilized in salineactive treatment drug 'Apitox, purified honeybee toxin, lyophilized in saline' |
| histamine injection | Placebo comparator | Biological: histaminethe histamine injection produces a similar local effect of pain and erythema as the active drug |
Who may qualify
- Ages
- 30 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 |
|---|---|---|
| Apitox, purified honeybee toxin, lyophilized in salineAlso: Apitoxin in Koreaintradermal injections of 0.1mg apitox in 0.1ml WFI over 12 weeks treatment period, injections twice weekly range from 1 to 20 injections | Biological | Apitox, purified honeybee toxin, injections |
| histamineimitates pain and erythema of honeybee venom | Biological | histamine injection |
Primary outcome
WOMAC
Time frame: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up
WOMAC
2 secondary outcomes
PhGA
Time frame: from 4 wks global assessment through 12 wks
PGA
Time frame: from 4 wks throught the 12 wk treatment
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 13 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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 M. H. Kim, M.D. study chair
Apimeds, CEO
15 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 Apitox, purified honeybee toxin, lyophilized in saline and histamine in people with Osteoarthritis of the Knee, run by Apimeds, Inc. at 15 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 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. Some participants in this study may receive a placebo. 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?
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: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up). 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 13 Dec 2016.