Knee OsteoarthritisPhase 1NCT03576508
A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis
A Phase 1 study testing CNTX-4975-05, Qutenza and Lidocaine (without epinephrine) in people with Knee Osteoarthritis, run by Centrexion Therapeutics at 1 site in United States.
Trial summary
This is a Phase 1b, open-label, two-period, randomized crossover study in adult male and female participants with painful knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- CNTX-4975-05, Qutenza and Lidocaine (without epinephrine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2018to 6 Sep 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) between 18.0-35.0 kg/m^2
- Subject has moderate to severe painful osteoarthritis in one knee while walking (index knee); contralateral knee may or may not have osteoarthritis, pain should be none to mild in the non-index knee
- Confirmation of the OA of the index knee: American College of Rheumatology (ACR) diagnostic criteria
- Subject has intact skin at the location of the dosing sites (patch or injection)
Who cannot join
- Subject has any other form of arthritis, such as, but not limited to, rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematosus, etc.
- Subject has a dermatological condition that may contraindicate participation, including any compromise in skin integrity at the CNTX-4975-05 injection site or the Qutenza® skin application site, e.g., severe or cystic acne, psoriasis, eczema, atopic dermatitis, active or treated cancer, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
Well Pharma Medical Research, Corp
Miami, Florida, 33143
About this study
Official title: A Two-Period Crossover Study to Compare the Systemic Exposure to Trans-Capsaicin and Cis-Capsaicin From an Intra-Articular Injection of CNTX-4975-05 (Trans-capsaicin for Injection) and Topical 8% Capsaicin Patch (Qutenza®) in Subjects With Painful Knee Osteoarthritis
This is a Phase 1b, open-label, two-period, randomized crossover study in adult male and female participants with painful knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- CNTX-4975-05, Qutenza, Lidocaine (without epinephrine)
- Keywords
- Osteoarthritis, Knee
- 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.
CNTX-4975-05Drug
Also called trans-capsaicin
1 mg (2mL) IA injection
QutenzaDrug
Also called cis-capsaicin
8% topical patch
Lidocaine (without epinephrine)Drug
15 mL IA injection of 2% lidocaine (without epinephrine)
| Study group | Role | What they receive |
|---|---|---|
| CNTX-4975-05 Intra-Articular (IA) Injection | Experimental | Receives IA injection into the most painful OA knee. Receives: Drug: CNTX-4975-05; Drug: Lidocaine (without epinephrine) |
| Topical 8% Capsaicin Patch | Active comparator | Receives Capsaicin Patch on posterior rib cage. Receives: Drug: Qutenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capsaicin Pharmacokinetics - AUC0-t
Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-t.
Measured: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Capsaicin Pharmacokinetics - AUC0-inf
Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-inf.
Measured: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Capsaicin Pharmacokinetics - Cmax
Single-dose systemic exposure to trans- and cis-capsaicin measured by Cmax.
Measured: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Secondary outcomes (3)
Knee Injury and Osteoarthritis Outcome Score (KOOS) Assessment
Change from baseline in KOOS of IA injected knees; 5-point Likert scale: 0 (no problems) to 4 (extreme problems); 5 subscales; each assessed separately
Measured: Day 1 (pre-dose) or Day 8 (pre-dose) [cross over trial Qutenza® 8% patch or CNTX-4975-05 intra-articular (IA) knee injection], and Week 8 (follow-up)
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
Number of participants with TEAEs, which includes laboratory test variables
Measured: Day 1 (post-dose), Day 8 (post-dose), and Week 8 (follow-up)
IA knee Lidocaine Systemic Pharmacokinetics - Concentration
System exposure to lidocaine measured by plasma concentration
Measured: Day 1 (pre-dose to 3 hours post-dose) or Day 8 (pre-dose to 3 hours post-dose) [Cross over trial Qutenza® 8% patch or CNTX-4975-05 IA knee injection]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start25 Jun 2018
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centrexion Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall Stevens, MD, Study chair, Centrexion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576508
- Sponsor's protocol ID
- CNTX-4975i-OA-102
- Status last verified
- Nov 2018
- First submitted
- 11 Jun 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Period Crossover Study to Compare the Systemic Exposure to Trans-Capsaicin and Cis-Capsaicin From an Intra-Articular Injection of CNTX-4975-05 (Trans-capsaicin for Injection) and Topical 8% Capsaicin Patch (Qutenza®) in Subjects With Painful Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03576508
- Acronym / sponsor ID
- CNTX-4975i-OA-102
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 3 Jul 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.
This is a Phase 1b, open-label, two-period, randomized crossover study in adult male and female participants with painful knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNTX-4975-05 Intra-Articular (IA) Injection | Experimental | Drug: CNTX-4975-05, Drug: Lidocaine (without epinephrine)Receives IA injection into the most painful OA knee. |
| Topical 8% Capsaicin Patch | Active comparator | Drug: QutenzaReceives Capsaicin Patch on posterior rib cage. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) between 18.0-35.0 kg/m^2
- Subject has moderate to severe painful osteoarthritis in one knee while walking (index knee); contralateral knee may or may not have osteoarthritis, pain should be none to mild in the non-index knee
- Confirmation of the OA of the index knee: American College of Rheumatology (ACR) diagnostic criteria
- Subject has intact skin at the location of the dosing sites (patch or injection)
Key exclusion criteria (2 listed)
- Subject has any other form of arthritis, such as, but not limited to, rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematosus, etc.
- Subject has a dermatological condition that may contraindicate participation, including any compromise in skin integrity at the CNTX-4975-05 injection site or the Qutenza® skin application site, e.g., severe or cystic acne, psoriasis, eczema, atopic dermatitis, active or treated cancer, etc.
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 |
|---|---|---|
| CNTX-4975-05Also: trans-capsaicin1 mg (2mL) IA injection | Drug | CNTX-4975-05 Intra-Articular (IA) Injection |
| QutenzaAlso: cis-capsaicin8% topical patch | Drug | Topical 8% Capsaicin Patch |
| Lidocaine (without epinephrine)15 mL IA injection of 2% lidocaine (without epinephrine) | Drug | CNTX-4975-05 Intra-Articular (IA) Injection |
Primary outcome
Capsaicin Pharmacokinetics - AUC0-t
Time frame: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-t.
Capsaicin Pharmacokinetics - AUC0-inf
Time frame: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Single-dose systemic exposure to trans- and cis-capsaicin measured by AUC0-inf.
Capsaicin Pharmacokinetics - Cmax
Time frame: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)
Single-dose systemic exposure to trans- and cis-capsaicin measured by Cmax.
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS) Assessment
Time frame: Day 1 (pre-dose) or Day 8 (pre-dose) [cross over trial Qutenza® 8% patch or CNTX-4975-05 intra-articular (IA) knee injection], and Week 8 (follow-up)
Incidence of treatment-emergent adverse events (TEAEs) (safety and tolerability)
Time frame: Day 1 (post-dose), Day 8 (post-dose), and Week 8 (follow-up)
IA knee Lidocaine Systemic Pharmacokinetics - Concentration
Time frame: Day 1 (pre-dose to 3 hours post-dose) or Day 8 (pre-dose to 3 hours post-dose) [Cross over trial Qutenza® 8% patch or CNTX-4975-05 IA knee injection]
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 14 Nov 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 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 CNTX-4975-05, Qutenza and Lidocaine (without epinephrine) in people with Knee Osteoarthritis, run by Centrexion Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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 14 Nov 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 States. 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?
Capsaicin Pharmacokinetics - AUC0-t (time frame: Day 1 (pre-dose to 12 hours post-dose) and Day 8 (pre-dose to 12 hours post-dose)). The study lists 3 primary outcomes in all. 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 14 Nov 2018.