HUPS: Hyalgan Use in Painful Shoulder

NCT00377624 | Completed Phase 3

• 1 other identifier: L_8229
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 1

Brief Summary

Three-arm, parallel, double-blind, masked observer, randomized, PB-Saline controlled clinical trial. In order to avoid problems in the interpretation of the final results due to disparate enrollment from various centers, the number of patients enrolled per site will be the same per site. Study patients will be randomized to receive either 20 mg sodium hyaluronate, 3 i.a. sodium hyaluronate injections, followed by 2 PBSaline mock i.a. injections or 5 i.a. PB-Saline control injections. One investigator will administer the injection and the joint assessor will be blinded to the study. The anterior or posterior approach for the shoulder injection will be used.

Conditions

Osteoarthritis of Shoulder

Outcome Measures

Primary Outcomes (1)

• Improvement in shoulder pain on movement in previous 24 hours, based upon 100 mm VAS score up to 3 months after baseline for the 3 i.a. and 5 i.a. sodium hyaluronate injections compared to PB-Saline control

Secondary Outcomes (2)

• Maintenance or improvement from baseline in shoulder pain on movement in previous 24 hours based upon 100 mm VAS score up to 6 months after baseline of

• sodium hyaluronate treated patients compared to PB-Saline.

Interventions

sodium hyaluronate DRUG

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic shoulder pain with all of the following: of at least 6 months, but not greater than 5 years duration without clinically significant improvement in shoulder pain over the past one month, and present at least 50% of the days during the previous month.
• Patients who have failed conventional therapy including but not limited to the following: NSAIDs; one or more i.a. or local peri-articular steroid injections and physiotherapy (a minimum of one month of previous physiotherapy treatment is required.
• At screening, patients on chronic analgesic/anti-inflammatory medication should have a VAS pain score of \>/= 30 mm and \</= 90 mm indicating a lack of adequate and sustained response to previous and current therapies. At screening, patients not on chronic analgesic/anti-inflammatory medication should have a VAS pain score of \>/= 40 mm and \</= 90 mm. If bilateral shoulder pain is present, the investigator will use the more painful shoulder.
• At baseline, after all analgesic/anti-inflammatory medications have been discontinued for 2 weeks, patients should have a VAS pain score of \>/= 40 mm and \</= 90 mm.
• Patients with a limitation of shoulder motion in at least 1 direction at screening and baseline for the following active range of motions: Abduction with scapula fixed must be \</= 80°; internal rotation in abduction must be ,/= 55°, and/or external rotation in abduction must be 180°. These limitations of shoulder motion are in comparison to normal expected ranges.
• Patients with a retained active Range Of Motion ("ROM") \>/= 30 percent in all directions at screening and baseline to rule out frozen shoulder. The ROM should be: \>/= 30° for abduction with scapula fixed, \>/= 30° external rotation, and \>/= 20° for internal rotation.
• Patients with at least one of the following conditions as examined and determined by Investigator: Osteoarthritis of the Glenohumeral Joint (OA), Rotator cuff tear (complete or partial), Adhesive capsulitis of the shoulder.
• Patients who are able to complete efficacy measurement questionnaires.
• Patients who are willing to discontinue all NSAIDs or other analgesic medication taken for their shoulder pain at least 2 weeks prior to baseline evaluation, with the exception of acetaminophen 500-1000 mg (1-2 tablets) q.i.d., p.r.n. (maximum 8 tablets or 4 grams per day) which would be sole rescue medication. Acetaminophen must not be taken within 24 hours of any visits or valuations. Patients must also be willing to abstain from any i.a. or peri-articular injections for the shoulder during the course of the trial, except for the assigned study product.

You may not qualify if:

• A. GENERAL MEDICAL CONDITIONS
• 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.
• Participation in an experimental drug/device study within the previous 30 days.
• 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.
• Significant bleeding diathesis.
• 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
• Major injury including sports related injury to the shoulder within the past year.
• Patients with chronic shoulder pain more than 5 years duration.
• 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.
• Surgery to the study joint within the previous 12 months.
• Inflammatory arthropathy such as rheumatoid arthritis, lupus, psoriatic arthritis or Milwaukee shoulder.
• Frozen shoulder involving either shoulder.
• Patients with clinically significant shoulder pain improvement in the past month.
• Gout or calcium pyrophosphate diseases involving the upper extremity that has flared within the previous 12 months.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Phyllis Diener, MT, ASCP

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Start: January 1, 2002
• Study Completion: September 1, 2004
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

US (1)