At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 68 enrolled
Drug / intervention
Durolane 3 ml, Durolane 4,5 ml, Durolane 6 mldevice
Likely dose
Durolane 3 ml, Durolane 4,5 ml, Durolane 6 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-Blind, Randomized Study of Three Different Volumes of Durolane in Subjects With Osteoarthritis of the Knee
In Brief
A Phase 2 clinical trial evaluating Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml for Knee Osteoarthritis. Completed, enrolled 68 participants across 3 sites.
Detailed Summary
The purpose of the study is to assess the safety and efficacy profiles of new single-injection volumes of Durolane in patients with knee OA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Osteoarthritis
CountriesSweden
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartJan 2011
Primary CompletionSep 2011
Study CompletionNov 2011
TodayJul 2026
First PostedDec 23, 2010
Enrollment StartJan 1, 2011
Primary CompletionSep 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.5 years ago
Interventions
Durolane 3 ml, Durolane 4,5 ml, Durolane 6 mldevice
Durolane is an intraarticular hyaluronic acid preparation