Osteoarthritis, KneePhase 1NCT03472677
The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
A Phase 1 study testing Ice Pack and Cooling Device, CNTX-4975-05 (trans-capsaicin) and Capsaicin in people with Osteoarthritis, Knee, run by Centrexion Therapeutics at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Ice Pack and Cooling Device, CNTX-4975-05 (trans-capsaicin) and Capsaicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Mar 2018to 3 Aug 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Ice Pack and Cooling Device, CNTX-4975-05 (trans-capsaicin), Capsaicin
- Keywords
- Osteoarthritis, Knee Pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice Pack and Cooling DeviceOther
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)Drug
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)Drug
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)Drug
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.
CapsaicinDrug
Four intradermal injections of capsaicin, two on each forearm.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine). Receives: Other: Ice Pack and Cooling Device; Drug: Capsaicin |
| Cohort 2 | Experimental | Controlled cooling wrap versus ice pack cooling. Receives: Drug: CNTX-4975-05 (trans-capsaicin); Drug: Capsaicin |
| Cohort 3 | Experimental | Controlled cooling parameters will be determined after evaluation of data from prior cohorts. Receives: Drug: CNTX-4975-05 (trans-capsaicin); Drug: Capsaicin |
| Cohort 4 | Experimental | Controlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts). Receives: Drug: CNTX-4975-05 (trans-capsaicin); Drug: Capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS): Injection-site Pain
Cohorts 2-4: Change in injection-site pain following intra-articular (IA) administration of CNTX-4975-05 (trans-capsaicin) scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Measured: Days 1 and 7
Secondary outcomes (7)
IA Temperature
Cohorts 1-4: IA temperature measurements.
Measured: Days 1 and 7
Numerical Pain Rating Scale (NPRS): Procedural Pain
Cohort 1: Procedural pain following single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine) using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Measured: Days 1 and 7
Numerical Pain Rating Scale (NPRS): Procedural Pain
Cohorts 2-4: Procedural pain following intradermal (ID) administration of the challenge agent capsaicin as a function of temperature scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Measured: Days 1 and 7
Numerical Pain Rating Scale (NPRS): Pain with Walking
Cohorts 2-4: Average pain with walking over the past 24 hours scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Measured: Screening through Day 42
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Cohorts 2-4: Calculation of KOOS for each painful osteoarthritis knee on a scale of 0 to 100 with 0 representing extreme problems and 100 representing no problems.
Measured: Screening through Day 42
Patient Global Impression of Change (PGIC)
Cohorts 2-4: Change in knee pain for each painful osteoarthritis knee scored using PGIC on a scale of 1 to 7 with 1 representing very much improved and 7 representing very much worse.
Measured: Screening through Day 42
Numerical Pain Rating Scale (NPRS): Thermal Pain
Cohorts 1-4: Thermal pain approximately two weeks following intradermal (ID) administration of the challenge agent capsaicin scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
Measured: Between Days 28 and 35 inclusive; and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start21 Mar 2018
- Primary completion27 Jul 2018
- Study completion3 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centrexion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall M. Stevens, MD, Study chair, Centrexion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472677
- Sponsor's protocol ID
- CNTX-4975i-OA-101
- Status last verified
- Dec 2018
- First submitted
- 4 Mar 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03472677
- Acronym / sponsor ID
- CNTX-4975i-OA-101
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 27 Jul 2018 (actual)
- Study completion
- 3 Aug 2018 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Other: Ice Pack and Cooling Device, Drug: CapsaicinA comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine). |
| Cohort 2 | Experimental | Drug: CNTX-4975-05 (trans-capsaicin), Drug: CapsaicinControlled cooling wrap versus ice pack cooling. |
| Cohort 3 | Experimental | Drug: CNTX-4975-05 (trans-capsaicin), Drug: CapsaicinControlled cooling parameters will be determined after evaluation of data from prior cohorts. |
| Cohort 4 | Experimental | Drug: CNTX-4975-05 (trans-capsaicin), Drug: CapsaicinControlled cooling with knee device versus no cooling (determined after evaluation of data from previous cohorts). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ice Pack and Cooling DeviceA comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine). | Other | Cohort 1 |
| 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). | Drug | Cohort 2 |
| 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. | Drug | Cohort 3 |
| 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. | Drug | Cohort 4 |
| CapsaicinFour intradermal injections of capsaicin, two on each forearm. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Numerical Pain Rating Scale (NPRS): Injection-site Pain
Time frame: Days 1 and 7
Cohorts 2-4: Change in injection-site pain following intra-articular (IA) administration of CNTX-4975-05 (trans-capsaicin) scored using NPRS on a scale of 0 to 10 with 0 corresponding to no pain and 10 corresponding to the worst pain imaginable.
7 secondary outcomes
IA Temperature
Time frame: Days 1 and 7
Numerical Pain Rating Scale (NPRS): Procedural Pain
Time frame: Days 1 and 7
Numerical Pain Rating Scale (NPRS): Procedural Pain
Time frame: Days 1 and 7
Numerical Pain Rating Scale (NPRS): Pain with Walking
Time frame: Screening through Day 42
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Screening through Day 42
Patient Global Impression of Change (PGIC)
Time frame: Screening through Day 42
Numerical Pain Rating Scale (NPRS): Thermal Pain
Time frame: Between Days 28 and 35 inclusive; and Day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall M. Stevens, MD study chair
Centrexion Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ice Pack and Cooling Device, CNTX-4975-05 (trans-capsaicin) and Capsaicin in people with Osteoarthritis, Knee, run by Centrexion Therapeutics at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (NPRS): Injection-site Pain (time frame: Days 1 and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.