A Study on the Efficacy of Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Leaf Extract in Adults With Osteoarthritis of the Knee. (13GOHJ)

KGK Science

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis of the Knee

Treatments

Other: Placebo

Dietary Supplement: Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract

Study type

Interventional

Funder types

Industry

Identifiers

NCT02604381

13GOHJ

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

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