Clinical trial NCT03472677: The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
Official title: A Phase 1b Study to Characterize the Effect of Injection Site Cooling on Pain Experienced After CNTX-4975-05 (Trans-capsaicin) Intra-articular and Capsaicin Intradermal Injections in Healthy Volunteers and Subjects With Bilateral Painful Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Knee Pain
Lead sponsor: Centrexion Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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).

Primary outcomes:
measure: Numerical Pain Rating Scale (NPRS): Injection-site Pain
timeFrame: Days 1 and 7
Secondary outcomes:
measure: IA Temperature
timeFrame: Days 1 and 7
measure: Numerical Pain Rating Scale (NPRS): Procedural Pain
timeFrame: Days 1 and 7
measure: Numerical Pain Rating Scale (NPRS): Procedural Pain
timeFrame: Days 1 and 7
measure: Numerical Pain Rating Scale (NPRS): Pain with Walking
timeFrame: Screening through Day 42
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Screening through Day 42
measure: Patient Global Impression of Change (PGIC)
timeFrame: Screening through Day 42
measure: Numerical Pain Rating Scale (NPRS): Thermal Pain
timeFrame: Between Days 28 and 35 inclusive; and Day 42
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
affiliation: Centrexion Therapeutics
name: Randall M. Stevens, MD
role: STUDY_CHAIR
References: