TREAD-20: Trial of Hyalgan Three Injection-Regimen for the Treatment of Knee Pain Due to Osteoarthritis

NCT00130468 | Completed Phase 4

• 1 other identifier: L_9385
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Hyalgan (sodium hyaluronate) DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients who are able to complete efficacy measurement questionnaires and can understand and read English or Spanish (Spanish forms will be provided).
• Patients who can perform the 50-foot walk test without the support of crutches or other assistive devices, except for canes. If patient uses a cane routinely in daily activities, then they can use it for their assessments. However, this use must remain stable for all assessments.
• Minimum flexion of 90 degrees in both knees.
• Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication taken for any condition, including their knee pain with the exception of acetaminophen, up to 1000 mg (2 tablets) four times a day (q.i.d.), as needed (p.r.n.) (maximum 8 tablets or 4 grams per day). These patients must be willing to use only acetaminophen as a rescue pain medication for the knee pain during the study period and refrain from even acetaminophen use 24 hours prior to any office visit. All other analgesic medications for any chronic condition must be stopped (see exceptions for acute treatment of transient flares of pain). Patients must also be willing to abstain from any intra-articular (i.a.) or peri-articular injections to the knee or surgery during the course of the trial, except for the assigned study product.
• Patients who, if they are currently taking low dose aspirin (325 mg/day or less), are willing to remain on a stable dose throughout the study and are willing to refrain from any aspirin dose 24 hours prior to any office visit.
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Inc

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Phyllis Diener

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: November 1, 2004
• Study Completion: May 1, 2006
• Last Updated: April 3, 2008

Record last verified: 2008-04

Locations

US (1)