Status:
COMPLETED
The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
Lead Sponsor:
Centrexion Therapeutics
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Cohort 1 Key
- 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
- 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
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03472677
Start Date
March 21 2018
End Date
August 3 2018
Last Update
December 19 2018
Active Locations (1)
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1
MAC Clinical Research
Manchester, United Kingdom