Healthy subjects with joint pain/discomfort, osteoarthritis Musculoskeletal Diseases Healthy subjects with joint pain/discomfort, osteoarthritis
Conditions
Interventions
Participants attend a baseline screening visit (visit one) that involves a medical history, medication review, urine test for pregnancy, anthropomorphic measures, and a physical examination. If partic
Sponsors
Unigen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females, aged 35 to 75 years 2. BMI < 35 kg/m2 3. Knee pain for at least 15 of the 30 days prior to the start of the study 4. Symptoms of knee pain for at least 6 months 5. Grade I, II or III using Kellgren-Lawrence classification according to the screening X-ray 6. Able to walk 7. VAS-D score of = 6 at the randomization visit. Subjects will have stopped taking his/her usual medication at the screening visit (which will be 7 to 28 days prior to the randomization visit) and will not have taken rescue medication for the 2 days prior to the randomization visit 8. For subjects with Type 2 Diabetes, has HgbA1c of = 7.5% 9. Surgically sterile, post-menopausal or agrees to use an acceptable method of birth control 10. Agrees to not use any new vitamin and/or mineral supplement until after study completion 11. Agrees to not take any dietary or herbal supplements until after study completion. Seven-day washout period prior to visit 2 allowed 12. Agrees to not take any dietary or herbal supplements purported to decrease inflammation, body pain and/or improve joint health including glucosamine and MSM. Thirty-day washout period prior to visit 2 allowed 13. Willing and able to comply with the protocol including: attending 6 visits and discontinuing his/her usual OA medication and only taking acetaminophen in addition to the study product throughout the study period 14. Able to understand and sign the informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Active heart disease or presence of a pacemaker 2. Cerebrovascular disease 3. Uncontrolled high blood pressure (if deemed clinically significant by the investigator) 4. Renal or hepatic impairment/disease 5. Type I diabetes 6. Bipolar disorder 7. Parkinson’s disease 8. Neuromuscular disease 9. Unstable thyroid disease 10. Immune disorder (such as HIV/AIDS) 11. Multiple sclerosis or any other autoimmune disorder 12. Any inflammatory arthritic condition 13. Acute septic arthritis 14. Fibromyalgia or other chronic pain syndromes (OA in locations other than knee allowed) 15. Gout, pseudogout and hyperuricemia 16. Paget’s disease 17. Active peptic ulcer disease and/or history of upper gastrointestinal bleeding 18. Any medical condition deemed exclusionary by the Principal Investigator (PI) 19. A history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening 20. A history of psychiatric illness requiring hospitalization in the past 6 months 21. Ssignificant injury to the target joint within the past 12 months 22. History of joint replacement surgery at the index knee 23. History of arthroscopic surgery on the affected knee in the past 12 months or plans to have surgery in the next 6 months 24. Sulfa allergy or an allergy to sulphonamide 25. Allergy to shellfish and/or shrimp 26. Known allergy or sensitivity to any of the ingredients in the test product 27. Subjects with low blood pressure can only be included with PI approval due to potential worsening with Acacia catechu (Senegalia catechu). 28. Treated with oral corticosteroids within 4 weeks prior to screening 29. Intra-articular corticosteroids in the target joint within 3 months prior to screening 30. Hyaluronic acid injected in the target joint within 6 months prior to screening 31. Currently taking anticoagulants or antiplatelets 32. Unstable dose of medication (defined as fewer than 90 days at the same dose) 33. Currently taking any medication deemed exclusionary by PI 34. Evidence of hepatic or renal dysfunction as evidenced by ALT, AST, AP being > 2 times the upper limit of normal or serum creatinine value > 1.5 times the upper limit of normal or other clinically significant abnormal clinical laboratory value per PI discretion 35. History of drug or alcohol abuse in the past 12 months 36. Plans to have surgery over the next 12 weeks 37. Pregnant, lactating, or planning to become pregnant during the study period 38. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data 39. Participating or has participated in another research study within 30 days prior to visit 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of UP 1306 is measured using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain sub-score at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute effect of UP 1306 is measured using the Visual Analog Scale (VAS) discomfort ratings and the rescue medication use at 12 weeks. | — |
Countries
United States of America
Outcome results
None listed