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Osteoarthritis of ShoulderPhase 3NCT00377624

HUPS: Hyalgan Use in Painful Shoulder

A Phase 3 study testing sodium hyaluronate in people with Osteoarthritis of Shoulder, run by Sanofi at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Osteoarthritis of Shoulder
What is being tested?
sodium hyaluronate
How many people
602 participants
Where
1 siteUnited States
Study dates
Jan 2002to Sep 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • Patients who never received i.a. or peri-articular corticosteroid therapy for the signal shoulder. This includes patients with contraindication(s) to corticosteroids.
  • 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.
  • Patients with shoulder X-ray findings of acute fractures, severe loss of bone density, a vascular necrosis and/or severe deformity.
  • Patients with documented evidence of clinically significant shoulder joint deformities.
  • 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.
  • 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.
  • Patients with Kellgren-Lawrence Stage IV osteoarthritis of the glenohumeral joint.
  • Any arthrogram of the signal joint within the past 3 months.
  • CONCOMITANT CONDITIONS, DISEASES, MEDICATIONS AND/OR CLINICAL HISTORY.
  • Patients with known allergies to acetaminophen, lidocaine, hyaluronan, or avian products.
  • 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.
  • Patients with a recurrent medical history of severe allergic or immune-mediated reactions.
  • Patients with active infection of the skin in the vicinity of the potential injection site.
  • Patients taking any agent reported to have symptom relief for arthritis or be a disease/structure modifying drug.
  • Patients on concomitant therapy with anticoagulants.
  • 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.
  • 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.
  • Patients participating in any clinical trial within one month of trial entry.
  • 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.
  • Patients unable to legally comprehend the details and nature of the study.
  • Patients who - in the judgment of the clinician - are likely to violate the protocol regulations or unlikely to complete the study for any reason.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sanofi-Aventis

    Bridgewater, New Jersey, 08807

Other trials in United States

About this study

Official title: Sodium Hyaluronate for Treatment of Chronic Painful Shoulder With Limitation of Motion Due to Glenohumeral Joint Osteoarthritis, Rotator Cuff Tear and/or Primary or Secondary Adhesive Capsulitis

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.

Being tested
sodium hyaluronate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sodium hyaluronateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. 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

  2. sodium hyaluronate treated patients compared to PB-Saline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2006 (estimated)
  2. Study startJan 2002
  3. Study completionSep 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
602 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00377624
Sponsor's protocol ID
L_8229
Status last verified
Jan 2011
First submitted
14 Sep 2006
Last updated
11 Jan 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sodium hyaluronate in people with Osteoarthritis of Shoulder, run by Sanofi at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00377624.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2011.

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