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

NCT02604381 | Completed Phase 2

• 1 other identifier: 13GOHJ
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 subjects with osteoarthritis of the knee.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; Knee; Glucosamine Sulfate; Ginkgo Biloba; WOMAC; Joint Health Wellness; Interleukin-1-beta

Outcome Measures

Primary Outcomes (1)

• WOMAC™ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain

  Assessed at screening and every visit.

  12 weeks

Secondary Outcomes (8)

• WOMAC™ Osteoarthritis Index Pain Subscale as a measure of Osteoarthritis pain

  12 weeks

• WOMAC™ Osteoarthritis Index Total Score as a measure of Osteoarthritis

  12 weeks

• WOMAC™ Osteoarthritis Index Stiffness Score as a measure of Osteoarthritis stiffness

  12 weeks

• WOMAC™ Osteoarthritis Index Physical Fuction Score as a measure of Osteoarthritis Physical Function

  12 weeks

• Rand SF-36 questionnaire score as a measure of Quality of Life

  12 weeks

Other Outcomes (5)

• Safety Blood Panel

  Over 12 weeks

• Blood Pressure

  Over 12 weeks

• Heart Rate

  Over 12 weeks

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract DIETARY_SUPPLEMENT

Glucosamine Sulfate Potassium Chloride/Ginkgo Biloba Extract

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• KGK Science Inc.: lead
• Joint Health Wellness Group, LLC.: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 13, 2015
• Study Start: November 1, 2015
• Primary Completion: June 19, 2017
• Study Completion: June 19, 2017
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

CA (1)