- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02604381
A Study on the Efficacy of Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Leaf Extract in Adults With Osteoarthritis of the Knee. (13GOHJ)
August 9, 2017 updated by: KGK Science Inc.
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5R8
- KGK Synergize Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glucosamine Sulfate Potassium Chloride/Ginkgo Biloba Extract
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.
|
|
Placebo Comparator: Placebo
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WOMAC™ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain
Time Frame: 12 weeks
|
Assessed at screening and every visit.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WOMAC™ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain
Time Frame: 12 weeks
|
Measured at screening and every visit.
Within group changes assessed
|
12 weeks
|
WOMAC™ Osteoarthritis Index Total Score as a measure of Osteoarthritis
Time Frame: 12 weeks
|
Measured at screening and every visit
|
12 weeks
|
WOMAC™ Osteoarthritis Index Stiffness Score as a measure of Osteoarthritis stiffness
Time Frame: 12 weeks
|
Measured at screening and every visit
|
12 weeks
|
WOMAC™ Osteoarthritis Index Physical Fuction Score as a measure of Osteoarthritis Physical Function
Time Frame: 12 weeks
|
Measured at screening and every visit
|
12 weeks
|
Rand SF-36 questionnaire score as a measure of Quality of Life
Time Frame: 12 weeks
|
Measured at every visit
|
12 weeks
|
Cartilage Oligomeric Matrix Protein (COMP)
Time Frame: 12 weeks
|
12 weeks
|
|
IL-1 Beta
Time Frame: 12 weeks
|
12 weeks
|
|
Amount of rescue medication used
Time Frame: 12 weeks
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety Blood Panel
Time Frame: Over 12 weeks
|
Over 12 weeks
|
Blood Pressure
Time Frame: Over 12 weeks
|
Over 12 weeks
|
Heart Rate
Time Frame: Over 12 weeks
|
Over 12 weeks
|
BMI
Time Frame: Over 12 weeks
|
Over 12 weeks
|
Incidence of Adverse Events
Time Frame: Over 12 weeks
|
Over 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
June 19, 2017
Study Completion (Actual)
June 19, 2017
Study Registration Dates
First Submitted
November 10, 2015
First Submitted That Met QC Criteria
November 10, 2015
First Posted (Estimate)
November 13, 2015
Study Record Updates
Last Update Posted (Actual)
August 11, 2017
Last Update Submitted That Met QC Criteria
August 9, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13GOHJ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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