ClinicalTrials.Veeva

Menu

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

C

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)

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)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems