NCT00377624

CompletedPhase 3

HUPS: Hyalgan Use in Painful Shoulder

Sanofi Source

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Other study identifiers

Sponsor study identifier

L_8229

Study Type

interventional

Reported enrollment (type unavailable)

602

Locations

1 country

Sites

1

Timeline

Study Start

January 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

September 2004

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 602 participants
Study completion date: September 2004
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2002
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
September 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 14, 2006
Actual (reported)
First Posted
September 18, 2006
Actual (reported)

Last Updated: January 11, 2011
Status Verified: January 2011
Last Update Submitted: January 10, 2011

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 hyaluronateDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age35 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Sanofi
Industrylead

Study Sites (1)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

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 2002

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

September 2004

Date type not reported

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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.
+22 more criteria

Contact the study team to confirm eligibility.

This date has not been verified as actual or estimated.

Last Updated

January 11, 2011

Record last verified: 2011-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00377624
Data provider: ClinicalTrials.gov
Source updated: 2011-01-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:30 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations