A Double Blind, Randomized Trial of Intra-Articular Injections of 20 mg of Hyalgan® for the Treatment of Knee Pain Due to Osteoarthritis (Three Injection-Regimen for Efficacy And Duration-20 mg/2mL Dose: Tread-20)

Sanofi1 site in 1 country150 target enrollmentNovember 2004

ConditionsOsteoarthritis

DrugsHyalgan (sodium hyaluronate)

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Sanofi
Enrollment: 150
Locations: 1
Primary Endpoint: Improvement in pain due to OA of the knee after 50-foot walk on a flat surface based upon 100 mm VAS score for up to 6 months after Baseline for the HYALGAN treated group compared to PB-Saline control
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the efficacy and safety of intra-articular injections of 20 mg/2mL dose HYALGAN in patients with pain due to osteoarthritis (OA) of the knee.

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

May 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Patients having given their written informed consent, prior to participating in the trial.
•Patients of either sex \>= 40 years of age and of sufficient good health that they will be able to complete the 6-month follow-up.
•Patients with signs and symptoms of osteoarthritis of at least one knee:
•Diagnosed according to ACR criteria.
•Based upon a knee X-ray performed within 6 months prior to Screening, the radiograms must be classified as a Grade II or III for osteoarthritis of the knee according to the Kellgren \& Lawrence grading system based upon a radiologist's written report or individual certified for reading knee radiograms. (Sharpening of the tibial spine is not considered to be an osteophyte).
•Patients with symptoms consistent with osteoarthritis of the knee for at least 6 months prior to Screening. These symptoms must include knee joint pain, and may include crepitus, swelling and/or effusion of the knee.
•At Screening, patients on any analgesic/anti-inflammatory medication should have a visual analogue scale (VAS) pain score after walking on a 50 ft flat surface of \> 30 mm but \< 90 mm using a 100 mm scale. If patients are not taking any analgesic/anti-inflammatory medication or have not taken any pain medication (prescription \[Rx\] or over-the-counter \[OTC\]) in the previous 3 days from Screening then they should have a VAS pain score after walking on a 50 ft flat surface of \> 40 mm but \< 90 mm. If bilateral knee pain is present, the investigator will select the more painful knee.
•At Screening and Baseline, if there is bilateral OA of the knee involvement, patients must have a VAS pain score for walking on a 50 ft flat surface of \< 30 mm in the less painful contralateral knee at the Baseline assessment. A patient scoring an acceptable VAS pain score at Screening but failing to meet the inclusion and exclusion criteria at Baseline can not be randomized and enrolled.
•At Baseline, after all analgesic/anti-inflammatory medications have been discontinued for 2 weeks (withdrawal from acetaminophen rescue medication for at least 24 hours prior to Baseline assessment), patients should have a VAS pain score of \> 40 mm but \< 90 mm immediately after the 50-foot walk on a flat surface. Again, if bilateral knee pain is present, the investigator will select the more painful knee and the contralateral knee must have a VAS pain score of \< 30 mm.
•Patients must have had knee pain in the signal knee on at least 50% of the days in the month preceding Screening.

Exclusion Criteria

•Women of childbearing potential may not be entered if:
•their pregnancy tests (urine test) are positive,
•they are nursing,
•they do not use an effective method of contraception until all follow-up procedures are complete. (Methods of contraception considered effective are an oral, injectable or implanted contraceptive agent, or an intra-uterine device with a failure rate of 1% per year, and abstinence).
•Patients participating in an experimental drug/device study or any clinical trial within the previous 30 days prior to Screening.
•Patients with a prior history of any malignancy with the exception of basal cell carcinoma of the skin treated more than 2 years prior to Screening, unless specific permission/waiver by the Sponsor is granted.
•Patients having significant bleeding diathesis.
•Patients that are currently under litigation for injuries related to the study knee or other injuries that might interfere with their completion of the study protocol.
•Musculoskeletal Related
•Patients having any major injury (including sports) to the study knee in past 12 months.

Outcomes

Primary Outcomes

Improvement in pain due to OA of the knee after 50-foot walk on a flat surface based upon 100 mm VAS score for up to 6 months after Baseline for the HYALGAN treated group compared to PB-Saline control