The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee

Centrexion Therapeutics

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis, Knee

Treatments: Drug: Capsaicin; Other: Ice Pack and Cooling Device; Drug: CNTX-4975-05 (trans-capsaicin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03472677

CNTX-4975i-OA-101

Details and patient eligibility

About

A clinical study to measure the effects of injection-site cooling on pain experienced after knee injections of capsaicin in healthy subjects and in patients with knee osteoarthritis.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Cohort 1 Key Inclusion Criteria:

• Subject is aged between 18 and 45 years, inclusive.
• Subjects Body Mass Index (BMI) is between 18 and 32 kg/m^2, inclusive and subject's weight is greater than or equal to 50 kg.
• Subjects must be in good health, in the opinion of the Investigator, as determined by a medical history, physical examination, clinical laboratory tests, vital signs and 12 lead electrocardiogram (ECG).

Cohort 1 Key Exclusion Criteria:

• Subject has had a clinically significant illness that has not completely resolved in the four weeks before screening.
• Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.

Cohorts 2-4 Key Inclusion Criteria:

• Subject is aged between 45 and 75 years, inclusive.
• Subject's BMI is between 18 and 32 kg/m^2, inclusive and subject's weight is greater than or equal to 50 kg.
• Subject has a diagnosis of bilateral moderate to severe painful knee OA (subjects will be required to have a score on Pain with walking in the previous 24 hours, of 4 to 9, inclusive NPRS 0-10). The condition must be chronic with a history of painful arthritis for at least 3 months prior to entry in the study.

Cohorts 2-4 Key Exclusion Criteria:

• Subject has had a clinically significant illness, other than osteoarthritis, that has not completely resolved in the four weeks before screening.
• Subject has a history of neurological disorder which may impact the perception of pain or impairs the subject's ability to fully participate in the trial.
• Subject has used analgesic medications in the 2 days prior to dosing, except for paracetamol, as needed.
• Subject has used topical medications applied to the knee for OA pain (including capsaicin, lidocaine, prescription or OTC medications) from 90 days prior to screening through to dosing.
• Subject has been injected with corticosteroids in the knee 90 days prior to screening through to dosing.
• Subject currently uses opioids for any condition other than OA knee pain (maximum dose 15 mg hydrocodone, or equivalent, per day prescribed by a physician).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Cohort 1

Experimental group

Description:

A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).

Treatment:

Other: Ice Pack and Cooling Device

Drug: Capsaicin

Cohort 2

Experimental group

Description:

Controlled cooling wrap versus ice pack cooling.

Treatment:

Drug: CNTX-4975-05 (trans-capsaicin)

Drug: CNTX-4975-05 (trans-capsaicin)

Drug: Capsaicin

Drug: CNTX-4975-05 (trans-capsaicin)

Cohort 3

Experimental group

Description:

Controlled cooling parameters will be determined after evaluation of data from prior cohorts.

Treatment:

Drug: CNTX-4975-05 (trans-capsaicin)

Drug: CNTX-4975-05 (trans-capsaicin)

Drug: Capsaicin

Drug: CNTX-4975-05 (trans-capsaicin)

Cohort 4

Experimental group

Description:

Controlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts).

Treatment:

Drug: CNTX-4975-05 (trans-capsaicin)

Drug: CNTX-4975-05 (trans-capsaicin)

Drug: Capsaicin

Drug: CNTX-4975-05 (trans-capsaicin)