NCT04231318Phase 3Completed

Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain

Study sponsor: Anika Therapeutics, Inc. · ANIK

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2022-05-16Actual

Enrollment · participants231Actual

Source updated2023-08-09Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Osteoarthritis, Knee

Treatments or interventions studied

CingalDrugAlso known as HA + TH
Triamcinolone Hexacetonide (TH)DrugAlso known as TH
PlaceboDrugAlso known as Saline

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score; description: The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative value for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. A larger negative value indicates lower pain levels and a better outcome.; timeFrame: 26 Weeks; measure: Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score; description: The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment.; timeFrame: 18 Weeks; measure: Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score; description: The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment.; timeFrame: 12 Weeks; measure: Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score; description: The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment.; timeFrame: 6 Weeks; measure: Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score; description: The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment.; timeFrame: 3 Weeks; measure: Change From Baseline in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score; description: The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative number for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment.; timeFrame: 1 Week

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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