Cingal Study for Knee Osteoarthritis

A

Anika Therapeutics

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Device: Hyaluronic Acid and TH (Cingal®)
Device: Saline
Device: Hyaluronic Acid (Monovisc®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01891396
Cingal 13-01

Details and patient eligibility

About

The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis.

Full description

This study compared three groups of subjects. Group One received a single injection of Cingal (Hyaluronic Acid plus Triamcinolone Hexacetonide). Group Two received a single injection of Monovisc (Hyaluronic Acid). Group Three received a single injection of saline as a placebo.

Enrollment

368 patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject is 40 - 75 years old with a Body Mass Index (BMI)≤ 40 kg/m2
  • Subject has Kellgren-Lawrence (K-L) severity grade I, II, or III in the index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I, or II.

Exclusion criteria

  • Subject received an intra-articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the informed consent form (ICF).
  • Subject had an arthroscopy of either knee within 3 months of signing the informed consent form (ICF).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

368 participants in 3 patient groups, including a placebo group

Saline
Placebo Comparator group
Description:
Single injection of 0.9% saline supplied as a 4 milliliter (mL) unit dose in a 5mL glass syringe
Treatment:
Device: Saline
Hyaluronic Acid and TH (Cingal®)
Experimental group
Description:
Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe
Treatment:
Device: Hyaluronic Acid and TH (Cingal®)
Hyaluronic Acid (Monovisc®)
Active Comparator group
Description:
Single injection of sodium hyaluronate supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe
Treatment:
Device: Hyaluronic Acid (Monovisc®)

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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