CompletedPhase 4

Durolane Compared to Saline in Patients With Unilateral Knee Osteoarthritis

United Kingdom218 participantsStarted 2003-02

Plain-language summary

This was a study that compared Durolane injections to saline injections in the treatment of unilateral osteoarthritis of the knee. The patients were randomly assigned one of the two treatments unaware of which treatment they received. The study was conducted at 13 centers in Germany, the United Kingdom and Sweden. Patients were followed for six weeks after study treatment.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Osteoarthritis according to ACR (American College of Radiology) criteria for the knee * WOMAC pain score in the range 7 to 17 * Significant knee pain for the majority of days during the past 3 months * Patient normally active, not bedridden or confined to a wheelchair and able to walk 50 meters without the help of a walker, crutches or a cane * Patient has attempted but not responded adequately to non-pharmacological therapy(ies) * Patient co-operative and able to communicate effectively with the investigators * Signed informed consent obtained Exclusion Criteria: * Bilateral knee osteoarthritis * Osteoarthritis or clinically significant pain from other part of the musculoskeletal system than the study knee * Kellgren Lawrence radiographic score grade IV for the study knee * Change in physical therapy/occupational therapy for the knee within the last 3 months * Treatment with nonsteroidal antiinflammatory drugs (NSAIDs) (including topical agents for the study knee) during the last week (or 5 half-lives of the drug, whichever is longer) prior to baseline visit * Treatment with non-NSAID topicals such as capsaicin for the knee within the last 3 days * Intra-articular injection with corticosteroids in the study knee within the last 3 months * Use of systemic steroids (excluding inhalation steroids) within the last 3 months * Intra-articular injections with hyaluronic acid in the study knee within the last 9 months * Treatment with glucosamine/chondroitin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of responders at 6 weeks.

Timeframe: At 6 weeks after treatment

Trial details

NCT IDNCT01806207

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-04

View on ClinicalTrials.gov More Unilateral Knee Osteoarthritis trials