OsteoarthritisPhase 3NCT00577330
Efficacy of Myalgesin™ to Support Joint Function in Patients With Knee Osteoarthritis
A Phase 3 study testing Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract) in people with Osteoarthritis, run by ProThera, Inc. at 1 site in United States.
Trial summary
Myalgesin is a botanical preparation consisting of celery seed extract,extract of dried Boswellia serrata, and dried extract of Phellodendron bark. Component of these extracts have been shown to exert anti-inflammatory effects and to inhibit cyclooxygenase and 5-lipooxygenase. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2008
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 50-years or older.
- Patients with symptomatic osteoarthritis of the knees as defined by the American College of Rheumatology criteria(traditional format).
- At least moderate pain in the knee (rated at 40 or greater by the subject on a visual analogue scale) for most days during the last month.
- Use of analgesic or anti-inflammatory agents for control of pain for at least 1 month.
- Baseline functional capacity class 1 to 3, in which class 1 is complete ability to carry out usual activities without handicap,class 2 is ability to adequately conduct usual activities despite handicap of discomfort or limited mobility of one or more joints,and class 3 is limited ability to carry out usual activities. (American Rheumatism Association functional class)
- Documented radiographic changes of osteoarthritis on a previous knee radiograph (Kellgren-Lawrence grade of 2 or more).
Who cannot join
- Age <50-years.
- Body mass index (BMI) equal to or greater than 35 kg/m2.
- Baseline functional class 4 with the subject bedridden or confined to wheelchair, largely or wholly incapacitated and capable of little or no self-care. (American Rheumatism Association functional class)
- Inflammatory arthritis, gout, pseudogout, or Paget's disease.
- Presence of chronic pain syndromes, such as fibromyalgia or reflex sympathetic dystrophy, that may interfere with the assessment of joint symptomatology.
- Severe bursitis of the knee.
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- History of acute joint trauma within 30 days of study entry.
- Complete loss of articular cartilage.
- History of total knee replacement.
- Intra-articular/intramuscular corticosteroids within 30 days of study entry.
- Intra-articular hyaluronan and hyalans within 30 days of study entry.
- History of gastrointestinal bleeding within 1 year of study entry.
- Active peptic ulcer disease, gastroesophageal reflux disease, or inflammatory bowel disease.
- Gastrointestinal tract ulceration within 30 days of study entry.
- Severe renal dysfunction defined as a serum creatinine greater than 2 mg/dL.
- Clinically significant liver disease including an aspartate aminotransferase or alanine aminotransferase >2 times the upper limit of normal.
- Unwillingness or inability to abstain from ethanol for the study duration.
- Significant bleeding disorder.
- History of gastric or duodenal surgery.
- Warfarin use.
- Sensitivity to acetaminophen or to any of the components of Myalgesin™.
- Pregnancy.
- Any serious medical, social or psychological condition that, in the opinion of the Principal Investigator, would disqualify a subject from participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Myalgesin™ for the Support of Joint Function in Patients With Osteoarthritis of the Knee - A Prospective Randomized Controlled Study
Myalgesin is a botanical preparation consisting of celery seed extract,extract of dried Boswellia serrata, and dried extract of Phellodendron bark. Component of these extracts have been shown to exert anti-inflammatory effects and to inhibit cyclooxygenase and 5-lipooxygenase. The study is based on the hypothesis that oral administrration of this botanical will support joint function in people with osteoarthritis of the knee and improve symptoms and mobility as measured by the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.
- Conditions
- Osteoarthritis
- Being tested
- Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)Dietary supplement
Twice daily
| Study group | Role | What they receive |
|---|---|---|
| Myalgesin | Experimental | Subjects receive Myalgesin twice daily Receives: Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract) |
| Acetaminophen | Active comparator | Subjects receive acetaminophen 1000 mg three times a day Receives: Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Measured: 90 days
Secondary outcomes (1)
Lesquesne Algofunctional Index
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startMay 2006
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProThera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stuart I Erner, MD, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577330
- Sponsor's protocol ID
- MYG-01-2006
- Other IDs
- 20052687
- Status last verified
- Dec 2007
- First submitted
- 18 Dec 2007
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Myalgesin™ for the Support of Joint Function in Patients With Osteoarthritis of the Knee - A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00577330
- Acronym / sponsor ID
- MYG-01-2006
- Conditions
- Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- ProThera, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Jan 2008 (estimated)
- First posted
- 20 Dec 2007 (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.
Myalgesin is a botanical preparation consisting of celery seed extract,extract of dried Boswellia serrata, and dried extract of Phellodendron bark. Component of these extracts have been shown to exert anti-inflammatory effects and to inhibit cyclooxygenase and 5-lipooxygenase. The study is based on the hypothesis that oral administrration of this botanical will support joint function in people with osteoarthritis of the knee and improve symptoms and mobility as measured by the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myalgesin | Experimental | Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)Subjects receive Myalgesin twice daily |
| Acetaminophen | Active comparator | Dietary Supplement: Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)Subjects receive acetaminophen 1000 mg three times a day |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women age 50-years or older.
- Patients with symptomatic osteoarthritis of the knees as defined by the American College of Rheumatology criteria(traditional format).
- At least moderate pain in the knee (rated at 40 or greater by the subject on a visual analogue scale) for most days during the last month.
- Use of analgesic or anti-inflammatory agents for control of pain for at least 1 month.
- Baseline functional capacity class 1 to 3, in which class 1 is complete ability to carry out usual activities without handicap,class 2 is ability to adequately conduct usual activities despite handicap of discomfort or limited mobility of one or more joints,and class 3 is limited ability to carry out usual activities. (American Rheumatism Association functional class)
Key exclusion criteria (23 listed)
- Age <50-years.
- Body mass index (BMI) equal to or greater than 35 kg/m2.
- Baseline functional class 4 with the subject bedridden or confined to wheelchair, largely or wholly incapacitated and capable of little or no self-care. (American Rheumatism Association functional class)
- Inflammatory arthritis, gout, pseudogout, or Paget's disease.
- Presence of chronic pain syndromes, such as fibromyalgia or reflex sympathetic dystrophy, that may interfere with the assessment of joint symptomatology.
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 |
|---|---|---|
| Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract)Twice daily | Dietary supplement | Acetaminophen, Myalgesin |
Primary outcome
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Time frame: 90 days
1 secondary outcome
Lesquesne Algofunctional Index
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
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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.
Stuart I Erner, MD principal investigator
Private Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Myalgesin™ (celery seed extract, Boswellia serrata extract, Phellodendron extract) in people with Osteoarthritis, run by ProThera, Inc. at 1 site 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 6 inclusion and 23 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 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index (time frame: 90 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 28 Dec 2007.