The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
NCT ID: NCT03472677
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2018-03-21
2018-08-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
Ice Pack and Cooling Device
A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
Capsaicin
Four intradermal injections of capsaicin, two on each forearm.
Cohort 2
Controlled cooling wrap versus ice pack cooling.
CNTX-4975-05 (trans-capsaicin)
Controlled cooling wrap vs ice pack cooling after single IA injection of 1 mg CNTX-4975-05 in each arm after single IA (15 mL) injection of 2% lidocaine (without epinephrine).
Capsaicin
Four intradermal injections of capsaicin, two on each forearm.
Cohort 3
Controlled cooling parameters will be determined after evaluation of data from prior cohorts.
CNTX-4975-05 (trans-capsaicin)
Controlled cooling parameters will be determined after evaluation of data from prior Cohort(s) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
Capsaicin
Four intradermal injections of capsaicin, two on each forearm.
Cohort 4
Controlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts).
CNTX-4975-05 (trans-capsaicin)
Controlled cooling with knee device vs no cooling (determined after evaluation of data from previous cohorts) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
Capsaicin
Four intradermal injections of capsaicin, two on each forearm.
Interventions
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Ice Pack and Cooling Device
A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
CNTX-4975-05 (trans-capsaicin)
Controlled cooling wrap vs ice pack cooling after single IA injection of 1 mg CNTX-4975-05 in each arm after single IA (15 mL) injection of 2% lidocaine (without epinephrine).
CNTX-4975-05 (trans-capsaicin)
Controlled cooling parameters will be determined after evaluation of data from prior Cohort(s) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
CNTX-4975-05 (trans-capsaicin)
Controlled cooling with knee device vs no cooling (determined after evaluation of data from previous cohorts) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
Capsaicin
Four intradermal injections of capsaicin, two on each forearm.
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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.
Exclusion Criteria
* 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 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).
18 Years
75 Years
ALL
Yes
Sponsors
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Centrexion Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Randall M. Stevens, MD
Role: STUDY_CHAIR
Centrexion Therapeutics
Locations
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MAC Clinical Research
Manchester, , United Kingdom
Countries
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Other Identifiers
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CNTX-4975i-OA-101
Identifier Type: -
Identifier Source: org_study_id