Osteoarthritis of the KneePhase 213GOHJNCT02604381
A Study on the Efficacy of Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Leaf Extract in Adults With Osteoarthritis of the Knee.
A Phase 2 study testing Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract in people with Osteoarthritis of the Knee, run by KGK Science Inc. at 1 site in Canada.
Trial summary
The primary objective of the study is to assess the effectiveness of alpha-D Glucosamine Sulfate/Standardized Extract of Ginkgo Biloba Leaf versus a comparator product on osteoarthritis pain as assessed by the between group change in WOMAC™ Osteoarthritis Index Pain Subscale using Visual Analogue Scale (VAS) scores in… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to 19 Jun 2017
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 45-70 years of age
- Body mass index (BMI) 18.0-39.9 kg/m2
- If female, subject is not of child bearing potential OR female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- Primary or secondary, unilateral or bilateral osteoarthritis of the knee (American College of Rheumatology Clinical Criteria for Classification) characterized as knee pain with at least 3 of the following:
- Age > 50 years
- Stiffness < 30 minutes
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- Crepitus
- Bony Tenderness
- Bony enlargement
- No palpable warmth
- Self reported difficulty performing at least one of the following activities because of knee pain:
- lifting and carrying groceries
- walking one-quarter of a mile
- getting in and out of a chair
- going up and down stairs
- mobility
- self-care activities
- Able to walk unassisted (may use walking stick, crutch, or knee brace)
- Availability for duration of the study period (2 week run-in +12 weeks)
- Subject agrees not to use over-the-counter medications or natural health products intended to treat OA pain during the run-in period and throughout the study (except the rescue medication provided).
- Subject using other therapies for OA, such as exercise, heat/cold therapy, joint protection and physiotherapy/occupational therapy agrees to continue these therapies as normal avoiding changes in frequency or intensity and to record therapies in the study diary
- Subject agrees not to start any new therapies for OA during the course of the study
- Agrees to maintain current exercise and dietary habits for the duration of the study
- Has given voluntary, written, informed consent to participate in the study
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Physical examination findings show severe articular inflammation
- Subject has a diagnosis of rheumatoid arthritis, fibromyalgia, spinal disorders or other musculoskeletal disease
- Subject has been recommended for knee surgery
- WOMAC Pain Scale Score <4 for total pain (average of question #1 to question #5) at screening and baseline
- Subject has kidney or liver disease, blood disorders, active cancer and/or HIV infection
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- Subjects with significant medical history or current metabolic disorders, thyroid disease, immune disorders and/or cardiovascular disease will be reviewed by the Qualified Investigator (QI). Subjects deemed by the QI to be at possible risk will not be permitted in this study.
- Subjects with a Type I or II diabetes
- Subjects with a history of seizures who are currently on medication to control seizures
- Subjects with hypertension will be reviewed by the Qualified Investigator (QI). If the subject is considered to be at risk they will not be permitted in this study
- Subjects with a history of reoccurring palpitations or dizziness
- Use of illicit drugs or history of drug or alcohol abuse with the past 2 years (currently having more than 2 standard alcoholic drinks per day)
- Planned surgery during the course of the trial
- Use of intra-articular, oral or parenteral corticosteroids, or other injectable prescription medication (e.g., Synvisc) within 2 months prior to randomization and during the trial
- Subjects taking prescription medication that affect blood coagulation (e.g. blood thinners, clotting factor replacements, acetylsalicylic acid)
- Subjects regularly taking over-the-counter medication (e.g. acetylsalicylic acid, ibuprofen) or natural health products (i.e. fish oils, vitamin E) that affect blood coagulation within 2 weeks of randomization
- Requires the use of prescription drugs to control pain (other than provided rescue medication)
- Use of oral or topical prescription or over the counter medications or natural health products for pain relief during the run-in period and during the trial (other than provided rescue medication, rescue medication should not be used within 72 hours prior to baseline and subsequent visits)
- Use of vitamins and minerals or natural health products/dietary supplements indicated for arthritis such as glucosamine and chondroitin sulfate within 2 weeks prior to the run-in period and during the trial
- Clinically significant abnormal laboratory results at screening (i.e. ≥ 2 times the ULN)
- Allergy or sensitivity to test product ingredients, including shellfish
- Allergy or sensitivity to acetaminophen, the rescue medication
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Placebo Controlled Parallel Study on the Efficacy of Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Leaf Extract in Adults With Osteoarthritis of the Knee.
The primary objective of the study is to assess the effectiveness of alpha-D Glucosamine Sulfate/Standardized Extract of Ginkgo Biloba Leaf versus a comparator product on osteoarthritis pain as assessed by the between group change in WOMAC™ Osteoarthritis Index Pain Subscale using Visual Analogue Scale (VAS) scores in subjects with osteoarthritis of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract, Placebo
- Keywords
- Osteoarthritis, Knee, Glucosamine Sulfate, Ginkgo Biloba, WOMAC, Joint Health Wellness, Interleukin-1-beta
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba ExtractDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Glucosamine Sulfate Potassium Chloride/Ginkgo Biloba Extract | Experimental | 2 capsules daily, immediately following a meal. 1 capsule in the morning, and 1 capsule in the evening, at approximately the same time each day. Receives: Dietary Supplement: Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract |
| Placebo | Placebo comparator | 2 capsules daily, immediately following a meal. 1 capsule in the morning, and 1 capsule in the evening, at approximately the same time each day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC™ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain
Assessed at screening and every visit.
Measured: 12 weeks
Secondary outcomes (8)
WOMAC™ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain
Measured at screening and every visit. Within group changes assessed
Measured: 12 weeks
WOMAC™ Osteoarthritis Index Total Score as a measure of Osteoarthritis
Measured at screening and every visit
Measured: 12 weeks
WOMAC™ Osteoarthritis Index Stiffness Score as a measure of Osteoarthritis stiffness
Measured at screening and every visit
Measured: 12 weeks
WOMAC™ Osteoarthritis Index Physical Fuction Score as a measure of Osteoarthritis Physical Function
Measured at screening and every visit
Measured: 12 weeks
Rand SF-36 questionnaire score as a measure of Quality of Life
Measured at every visit
Measured: 12 weeks
Cartilage Oligomeric Matrix Protein (COMP)
Measured: 12 weeks
IL-1 Beta
Measured: 12 weeks
Amount of rescue medication used
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion19 Jun 2017
- Study completion19 Jun 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Joint Health Wellness Group, LLC.
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604381
- Sponsor's protocol ID
- 13GOHJ
- Acronym
- 13GOHJ
- Status last verified
- Aug 2017
- First submitted
- 10 Nov 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Parallel Study on the Efficacy of Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Leaf Extract in Adults With Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT02604381
- Acronym / sponsor ID
- 13GOHJ / 13GOHJ
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, Knee, Glucosamine Sulfate, Ginkgo Biloba, WOMAC, Joint Health Wellness, Interleukin-1-beta
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Joint Health Wellness Group, LLC.
- Study start
- Nov 2015
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 13 Nov 2015 (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 primary objective of the study is to assess the effectiveness of alpha-D Glucosamine Sulfate/Standardized Extract of Ginkgo Biloba Leaf versus a comparator product on osteoarthritis pain as assessed by the between group change in WOMAC™ Osteoarthritis Index Pain Subscale using Visual Analogue Scale (VAS) scores in subjects with osteoarthritis of the knee.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucosamine Sulfate Potassium Chloride/Ginkgo Biloba Extract | Experimental | Dietary Supplement: Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract2 capsules daily, immediately following a meal. 1 capsule in the morning, and 1 capsule in the evening, at approximately the same time each day. |
| Placebo | Placebo comparator | Other: Placebo2 capsules daily, immediately following a meal. 1 capsule in the morning, and 1 capsule in the evening, at approximately the same time each day. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Male or female 45-70 years of age
- Body mass index (BMI) 18.0-39.9 kg/m2
- If female, subject is not of child bearing potential OR female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- Primary or secondary, unilateral or bilateral osteoarthritis of the knee (American College of Rheumatology Clinical Criteria for Classification) characterized as knee pain with at least 3 of the following:
- Age > 50 years
Key exclusion criteria (24 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- Physical examination findings show severe articular inflammation
- Subject has a diagnosis of rheumatoid arthritis, fibromyalgia, spinal disorders or other musculoskeletal disease
- Subject has been recommended for knee surgery
- WOMAC Pain Scale Score <4 for total pain (average of question #1 to question #5) at screening and baseline
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 |
|---|---|---|
| Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract | Dietary supplement | Glucosamine Sulfate Potassium Chloride/Ginkgo Biloba Extract |
| Placebo | Other | Placebo |
Primary outcome
WOMAC™ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain
Time frame: 12 weeks
Assessed at screening and every visit.
8 secondary outcomes
WOMAC™ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain
Time frame: 12 weeks
WOMAC™ Osteoarthritis Index Total Score as a measure of Osteoarthritis
Time frame: 12 weeks
WOMAC™ Osteoarthritis Index Stiffness Score as a measure of Osteoarthritis stiffness
Time frame: 12 weeks
WOMAC™ Osteoarthritis Index Physical Fuction Score as a measure of Osteoarthritis Physical Function
Time frame: 12 weeks
Rand SF-36 questionnaire score as a measure of Quality of Life
Time frame: 12 weeks
Cartilage Oligomeric Matrix Protein (COMP)
Time frame: 12 weeks
IL-1 Beta
Time frame: 12 weeks
Amount of rescue medication used
Time frame: 12 weeks
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 11 Aug 2017.
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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.
Tetyana Pelipyagina, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract in people with Osteoarthritis of the Knee, run by KGK Science Inc. at 1 site in Canada.
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 24 inclusion and 24 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 11 Aug 2017. 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 Canada. 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 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™ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain (time frame: 12 weeks). 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 11 Aug 2017.