Comparison of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee

• Sponsor: Genzyme, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00139295
• Collaborator: (none)
• Locations: 24
• Duration (Months): 35

Study Details

Study Description

Brief Summary

This is a clinical study to investigate the safety and efficacy of hylastan in treating patients with symptomatic osteoarthritis (OA) of the knee.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee	Device: Hylastan	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Comparison of the Efficacy and Safety of Hylastan to Methylprednisolone Acetate in Patients With Symptomatic Osteoarthritis of the Knee
• Study Start Date: Oct 1, 2004
• Actual Study Completion Date: Sep 1, 2007

Outcome Measures

Primary Outcome Measures

1. pain relief []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with OA of the knee

• Have tried but not been sufficiently helped by conservative treatment, such as weight reduction and pain medications

Exclusion Criteria:

• Prior or concomitant treatments that would impede measurement of safety and efficacy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Capstone Clinical Trials, Inc	Birmingham	Alabama	United States	35209
2	Hope Research Institute, LLC	Phoenix	Arizona	United States	85050
3	Tucson Orthopedic Institute, PC	Tucson	Arizona	United States	85712
4	Orthopaedic Specialties of Tampa Bay	Clearwater	Florida	United States	33756
5	Northwestern Center for Clinical Research	Chicago	Illinois	United States	60611
6	Midwest Orthopedics at Rush University Medical Center	Chicago	Illinois	United States	60612
7	Rockford Health Physicians	Rockford	Illinois	United States	61103
8	Bluegrass Orthopaedics/Bluegrass Musculoskeletal Research	Lexington	Kentucky	United States	40509
9	Orthopedic Specialists of Louisiana	Shreveport	Louisiana	United States	71101
10	Arthritis & Osteoporosis Center of Maryland	Frederick	Maryland	United States	21702
11	Clinical Pharmacology Study Group	Worcester	Massachusetts	United States	01610
12	Orthopedic Center for Joint Replacement and Sports	Grants Pass	Oregon	United States	97527
13	Coastal Orthopedic Associates	Conway	South Carolina	United States	29526
14	Unlimited Research	San Antonio	Texas	United States	78217
15	Arthritis Northwest	Seattle	Washington	United States	98166
16	Sir William Osler Health Institute	Hamilton	Ontario	Canada	L9C 7N4
17	Clinique du Sport	Merignac		France	33700
18	Centre Hospitalier Lyon-Sud, Service de Rhumatologie	Pierre Benite Cedex		France	69495
19	CHU Hôpital Trousseau Service de Rhumatologie	Tours		France	37044
20	St-Elisabeth Klinik, Orthopädisch Gemeinschaftspraxis	Heidelberg		Germany	69121
21	Orthopaedische Gemeinschaftspraxis	Weyhe-Kirchweyhe		Germany	28844
22	Southampton General Hospital, MRC Environmental Epidemiology Unit	Southampton	Hampshire	United Kingdom	SO16 6YD
23	Maidstone General Hospital & Tunbridge Wells NHS Trust	Maidstone	Kent	United Kingdom	ME16 9QQ
24	Whipps Cross University Hospital NHS Trust, Arthritis Assessment, Physiotherapy Department	Leytonstone	London	United Kingdom	E11 1NR

Sponsors and Collaborators

• Genzyme, a Sanofi Company

Investigators

• Study Director: Medical Monitor, Genzyme, a Sanofi Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00139295
• Other Study ID Numbers: AVS00103
• First Posted: Aug 31, 2005
• Last Update Posted: Feb 5, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by , ,: musculoskeletal; osteoarthritis of the knee
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Feb 5, 2014