HUPS: Hyalgan Use in Painful Shoulder

Exclusion Criteria

• •A. GENERAL MEDICAL CONDITIONS
• •1. Women of childbearing potential may not be entered if pregnant, nursing, or not using effective method of contraception until all follow-up procedures are complete.
• •2. Participation in an experimental drug/device study within the previous 30 days.
• •3. Prior history of any malignancy, with the exception of basal cell carcinoma of the skin treated more than 2 years ago, unless specific permission of the Sponsor is granted.
• •4. Significant bleeding diathesis.
• •5. Active liver disease, conjugated bilirubin, renal insufficiency, abnormal blood counts, or any clinically significant laboratory value, which the investigator feels, may affect the evaluation of the patient.
• •B. MUSCULOSKELETAL RELATED
• •1. Major injury including sports related injury to the shoulder within the past year.
• •2. Patients with chronic shoulder pain more than 5 years duration.
• •3. Any cervical spine disease that could confound the clinical assessment; chronic acromioclavicular disease, thoracic outlet syndrome, active epicondylitis, or symptomatic carpal tunnel disease, any musculoskeletal disease that could confound the diagnosis/evaluation of the painful shoulder, or any neurological etiology of the pain and any acute infection of the joint.
• •4. Surgery to the study joint within the previous 12 months.
• •5. Inflammatory arthropathy such as rheumatoid arthritis, lupus, psoriatic arthritis or Milwaukee shoulder.
• •6. Frozen shoulder involving either shoulder.
• •7. Patients with clinically significant shoulder pain improvement in the past month.
• •8. Gout or calcium pyrophosphate diseases involving the upper extremity that has flared within the previous 12 months.
• •9. Intra-articular or local peri-articular corticosteroid injections to the study joint or shoulder within the previous 3 months; or to any other joint within the previous month; or any oral corticosteroid within the previous month. Steroid inhalants are permitted if the patient has been on a stable regimen for the past month and remains on this regimen throughout the course of the trial. Low dose aspirin (325 mg or less) as an anti-thrombotic treatment is permitted if stable for one month prior to Screening and stable throughout the trial.
• •10. Patients who never received i.a. or peri-articular corticosteroid therapy for the signal shoulder. This includes patients with contraindication(s) to corticosteroids.
• •11. Intra-articular hyaluronan in the study joint within the previous 12 months. Use of glucosamine-or chondroitin sulfate-containing products unless at Screening the patient is on stable doses for at least 4 months and willing to remain on these stable doses throughout the course of the trial. Use of bisphosphonates unless at Screening the patient is on stable doses for the past month and willing to remain on these stable doses throughout the course of the trial.
• •12. Patients with shoulder X-ray findings of acute fractures, severe loss of bone density, a vascular necrosis and/or severe deformity.
• •13. Patients with documented evidence of clinically significant shoulder joint deformities.
• •14. If patients are receiving or performing physical therapy at screening, this physical therapy regimen must have been stable during the one-month preceding screening and remain stable throughout the course of the trial.
• •15. Patients with primary extra-articular shoulder syndromes in the absence of intra-articular disease such as uncomplicated impingement syndrome without limitation in ROM, bursitis and tendinitis without evidence of adhesive capsulitis.
• •16. Patients with Kellgren-Lawrence Stage IV osteoarthritis of the glenohumeral joint.
• •17. Any arthrogram of the signal joint within the past 3 months.
• •C. CONCOMITANT CONDITIONS, DISEASES, MEDICATIONS AND/OR CLINICAL HISTORY.
• •1. Patients with known allergies to acetaminophen, lidocaine, hyaluronan, or avian products.
• •2. Patients requiring chronic analgesia for any other condition (including chronic pain in the contralateral shoulder or another joint) that may interfere with the evaluations of the signal shoulder.
• •3. Patients with a recurrent medical history of severe allergic or immune-mediated reactions.
• •4. Patients with active infection of the skin in the vicinity of the potential injection site.
• •5. Patients taking any agent reported to have symptom relief for arthritis or be a disease/structure modifying drug.
• •6. Patients on concomitant therapy with anticoagulants.
• •7. Patients with any inter-current disease(s) or condition(s) that may interfere with the free use and evaluation of the affected shoulder for the 6-month course of the trial.
• •8. Patients with any inter-current chronic disease(s) or condition(s) that may predispose them to a high probability of interfering with the completion of the 6 month follow-up of the study such as peptic ulcer, liver disease, severe coronary disease, renal disease, cancer, pregnancy, alcoholism, drug abuse, mental state, or other clinically significant condition.
• •9. Patients participating in any clinical trial within one month of trial entry.
• •10. In the opinion of the clinical investigator a clinically significant abnormal laboratory test result(s) that may place the patient at a health risk, impact upon the study, or the patient's ability to complete the study.
• •11. Patients unable to legally comprehend the details and nature of the study.
• •12. Patients who - in the judgment of the clinician - are likely to violate the protocol regulations or unlikely to complete the study for any reason.