At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 242 enrolled
Drug / intervention
Cingal +2 morecombination
Likely dose
Not stated in 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.
An Open-Label, Follow-On Study to Cingal 13-01 to Evaluate the Safety of a Repeat Injection of Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide to Provide Symptomatic Relief of Osteoarthritis of the Knee
In Brief
A Phase 3 clinical trial evaluating Cingal for Osteoarthritis of the Knee. Completed, enrolled 242 participants across 10 sites in 3 countries.
Detailed Summary
The objective of this study is to evaluate the safety of an injection of Cingal® in subjects with Osteoarthritis (OA) of the knee who participated in Cingal 13-01, and who received either a Cingal, Monovisc, or saline injection in the 13-01 study. The safety evaluation will be done by a through examination of the incidence of adverse events and physical examination of the knee.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Knee
CountriesCzechia, Hungary, Poland
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartFeb 2015
First PostedMar 2015
Primary CompletionApr 2015
Study CompletionMay 2015
TodayJul 2026
First PostedMar 6, 2015
Enrollment StartFeb 1, 2015
Primary CompletionApr 1, 2015
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.3 years ago
Interventions
Cingalcombination
Injection into the knee
Cingalcombination
Injection into the knee
Cingalcombination
Injection into the knee