CompletedPhase 3

An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA

United States854 participantsStarted 2018-09-18

Plain-language summary

An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX 4975-05 Intra-articular Injection in Subjects with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain.

Who can participate

Age range40 Years – 95 Years

SexALL

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Inclusion criteria

✓. unilateral or bilateral OA, with the index knee having moderate to severe pain, and the contralateral knee having none to mild pain, OR
✓. unilateral or bilateral OA, with the index knee having moderate to severe pain and the other knee having had a PJR or TJR within 5 years of the Screening Visit. The knee with the PJR/TJR is not to be injected with CNTX-4975-05.

What they're measuring

Determination of Optimal Procedure for Administering CNTX-4975-05 With Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction

Timeframe: Day 1 assessments

Trial details

NCT IDNCT03661996

SponsorCentrexion Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-22

Results submitted2022-01-04

View on ClinicalTrials.gov More Knee Osteoarthritis trials