CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 576 enrolled
Drug / intervention
Cingal +2 morecombination
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Age 40-75 years with BMI ≤40 kg/m2
  • ✓Index knee with K-L grade I, II, or III on X-ray; contralateral knee K-L grade 0, I, or II
  • ✓At least 6 months of symptoms with ≥2 signs and ≥2 symptoms of OA (pain, crepitus, restricted movement, morning stiffness, bony enlargement, reduced function) despite conservative treatment
  • ✓WOMAC pain subscale score 40-90 mm in index knee and ≤30 mm in contralateral knee at baseline
Key exclusion· 20
  • ✕IA injection of hyaluronic acid and/or steroid in either knee within 6 months before enrollment or planned during the study
  • ✕Arthroscopy of either knee within 3 months before enrollment
  • ✕Open surgical procedure of knee, hip, or spine within 12 months before enrollment or planned during study
  • ✕Evidence or history of inflammatory, infectious, or metabolic joint diseases including septic arthritis, inflammatory joint disease, Reiter's syndrome, gout, pseudogout, osteochondritis dissecans, or heritable collagen disorders in the index knee

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03191903
NCT03191903Phase 3Completed
CompareCT.gov

Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal™) to Provide Symptomatic Relief of Osteoarthritis of the Knee

Anika Therapeutics, Inc.·interventional·Posted Jun 19, 2017·Updated Feb 24, 2022

In Brief

A Phase 3 clinical trial evaluating Cingal, Monovisc, and 1 other intervention for Knee Osteoarthritis. Completed, enrolled 576 participants across 19 sites in 2 countries.

Detailed Summary

This is a multi-center, randomized, double-blind, parallel group, active comparator controlled trial to evaluate the efficacy and safety of a single injection of Cingal for the relief of joint pain in subjects with OA of the knee.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Osteoarthritis
CountriesHungary, Poland
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 19, 2017
Enrollment StartMay 25, 2017
Primary CompletionApr 23, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.0 years ago

Interventions

Cingalcombination

Hyaluronic Acid with Triamcinolone Hexacetonide

Monoviscdevice

Hyaluronic acid

Triamcinolone Hexacetonidedrug

Triamcinolone Hexacetonide