Safety and Tolerability of 4975 in the Treatment of Moderate to Severe Knee Pain Due to Osteoarthritis (OA)

Centrexion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis of the Knee

Treatments: Drug: CNTX-4975

Study type: Interventional

Funder types: Industry

Identifiers

NCT00667654

114-02P

Details and patient eligibility

About

This study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. Secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.

Full description

This is a single site study. The study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. Pain in the treated knee will be assessed before, during and after administration of the study drug.

Enrollment: 54 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged 40 years or over.
• Body mass index (BMI) of 35 or less.
• History of OA of the knee for at least 1 year and has experienced pain in the target area for at least six months.
• X-Ray of the target knee.
• Willing and able to complete the study procedures.

Exclusion criteria

• Female patients who are pregnant or lactating or who plan to get pregnant.
• Clinically significant form of joint disease other than OA.
• Medical condition that could adversely impact the patient's participation, safety or affect the conduct of the study.
• Prior major trauma in the target knee or major surgeries such as partial or total knee arthroplasty.
• Arthroscopic surgery on the target knee within 6 months.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 5 patient groups

100-200 µg CNTX-4975

Experimental group

Description:

single dose

Treatment:

Drug: CNTX-4975

300-425 µg CNTX-4975

Experimental group

Description:

Total dose delivered as two separate lower doses

Treatment:

Drug: CNTX-4975

600-700 µg CNTX-4975

Experimental group

Description:

Total dose delivered as two separate lower doses

Treatment:

Drug: CNTX-4975

800 µg CNTX-4975

Experimental group

Description:

Total dose delivered as two separate lower doses

Treatment:

Drug: CNTX-4975

900-1000 µg CNTX-4975

Experimental group

Description:

Total dose delivered as two separate lower doses

Treatment:

Drug: CNTX-4975