drugset / Trial / NCT00144820

Hyaluronan Versus NaCl 20 Ml Versus Placebo in Knee Osteoarthritis

NCT00144820

Phase 4 Unknown 251 enrolled Glostrup University Hospital, Copenhagen
RandomizedParallel-groupDouble-blindTreatment

Summary

251 consecutive patients with knee arthrosis were randomized to one of three interventions: Four weekly injections of 2 ml isotonic saline (placebo), 2 ml sodium hyaluronate (hyaluronan) or 20 ml isotonic saline (excessive saline). They all suffered from clinically and radiologically verified arthrosis of the knee with daily pain that did not respond to treatment with analgetics. Results were evaluated at weeks 1,2,3,4,8,12,16 and 26. Biochemical markers for bone and cartilage degradation were measured in urine/blood.

Timeline

Start
1999-05
Primary completion
Completion
2001-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Hyaluronate Other / unclassified 2 ml Intrathecal
Subject sodium chloride Unknown 20 ml Intrathecal

Indications