Osteoarthritis, KneePhase 3NCT03429049
A Phase 3 Efficacy and Safety Study of Intra-articular CNTX-4975-05 (Capsaicin) vs Placebo in Subjects With OA Knee Pain
A Phase 3 study testing CNTX-4975-05 in people with Osteoarthritis, Knee, run by Centrexion Therapeutics at 33 sites in United States.
Trial summary
This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic, moderate-to-severe osteoarthritis (OA) knee pain. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- CNTX-4975-05
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 33 sitesUnited States
- Study dates
- 24 Jan 2018to 22 Nov 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between 40 and 95 years of age (inclusive) at the time of the Screening Visit with the ability to comply with answering the electronic diary using the study-provided tablet computers.
- Confirmation of osteoarthritis (OA) of the knee.
- Confirmation of OA of the index knee.
- Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.
- BMI ≤45 kg/m^2.
- Must have failed 2 or more prior therapies.
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- Females not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile, or practicing one of the following medically acceptable methods of birth control throughout the study period.
- Subject agrees to stay on their current pain medication (including over the counter (OTC) medications) from the time of Screening through Week 12. The current pain medication must be taken only for pain in the index knee, and not for another pain indication.
- Subject agrees to take only the allowed rescue medications for OA knee pain of the index knee from the time of Screening through study completion and agrees to use no topical medications for OA knee pain during the trial.
Who cannot join
- Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months.
- Prior arthroscopic surgery of the index knee within 6 months of Screening.
- Any painful conditions of the index knee due to joint disease other than OA.
- Periarticular pain from any cause.
- Pain in the non-index knee that is >3 on a numeric pain rating scale (NPRS) (0-10) when walking or at rest.
- Other chronic pain anywhere in the body that requires the use of analgesic medications.
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- Instability of the index knee.
- Misalignment (>10 degrees varus or valgus) of the index knee on standing.
- Documented history of neuropathic arthropathy or finding of bony fragmentation in the index knee with imaging.
- Physical/ occupational/ chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 30 days of Screening, or need for such therapy during the study.
- Plans to have surgery, other invasive procedures, or IA injections while participating in the study.
- Has used topical capsaicin on the index knee within 90 days of Screening.
- Current use of opioids for any condition other than for OA of the index knee.
- Corticosteroid injection into the index knee within 90 days of Screening.
- Received IA viscosupplementation (eg, Synvisc®, Hyalgan®) within 90 days of Screening.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Orange County Research Institute
Anaheim, California, 92801
Ortho Virginia
Arlington, Virginia, 22205
Tekton Research, Inc
Austin, Texas, 78745
Hassman Research Institute
Berlin, New Jersey, 08009
Alabama Orthopaedic Center - Research
Birmingham, Alabama, 35209
Cahaba Research, Inc
Birmingham, Alabama, 35242
Tufts Medical Center
Boston, Massachusetts, 02111
Core Healthcare Group
Cerritos, California, 90703
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911
Tampa Bay Medical Research, Inc
Clearwater, Florida, 33761
Metroplex Clinical Research Center
Dallas, Texas, 75231
Avail Clinical Research, LLC
DeLand, Florida, 32720
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Biosolutions Clinical Research Center
La Mesa, California, 91942
Clinical Research Consortium
Las Vegas, Nevada, 89119
Drug Studies America
Marietta, Georgia, 30060
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060
M&M Medical Center, Inc
Miami, Florida, 33185
Coastal Clinical Research, Inc
Mobile, Alabama, 36608
Tristan Medical Enterprises PC, dba
North Attleboro, Massachusetts, 02760
Providence Clinical Research
North Hollywood, California, 91606
Sensible Healthcare, LLC
Ocoee, Florida, 34761
Jewett Orthopaedic
Orlando, Florida, 32822
Mid America PolyClinic
Overland Park, Kansas, 66210
Clinical Investigations of Texas
Plano, Texas, 75075
Medical Associates Research Group
San Diego, California, 92123
Encompass Clinical Research
Spring Valley, California, 91978
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Atlanta Orthopaedic Institute, LLC
Stockbridge, Georgia, 30281
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603
Bone Joint & Spine Surgeons, Inc
Toledo, Ohio, 43623
Medical Research Associates, Inc
Traverse City, Michigan, 49686
Noble Clinical Research, LLC
Tucson, Arizona, 85704
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain
This is a phase 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic, moderate-to-severe osteoarthritis (OA) knee pain.
- Conditions
- Osteoarthritis, Knee
- Being tested
- CNTX-4975-05, Placebo
- Keywords
- analgesic, non-opioid, capsaicin, intra-articular, osteoarthritis, pain, knee pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNTX-4975-05Drug
Receiving CNTX-4975-05 injection
PlaceboDrug
Receiving Placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo of 2.0 mL for IA injection Receives: Drug: Placebo |
| CNTX-4975-05 | Experimental | Pre-filled glass syringes administered as a single 2.0 mL IA injection Receives: Drug: CNTX-4975-05 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
Average daily OA pain in the index knee while walking was evaluated using a 0 to 10 Numerical Pain Rating Scale (NPRS) (0 = no pain and 10 = worst possible pain). 0 was the best score and 10 was the worst score.
Subjects used an ePRO at bedtime (9:00 PM ± 3 hours) to record on a daily basis their average daily OA knee pain score with walking during the previous 24 hours.
Measured: Baseline, Week 12
Secondary outcomes (3)
Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score
The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).
The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome.
The pain dimension includes 5 items about the amount of pain experienced doing various activities (walking, stair climbing, nocturnal, at rest, weight bearing). The score ranges from 0 to 50.
Measured: Baseline, Week 12
Mean Change From Baseline WOMAC B (Stiffness) Dimension Total Score
The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).
The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome.
The stiffness dimension has 2 items: joint stiffness upon wakening and joint stiffness later in the day. The score ranges from 0 to 20.
Measured: Baseline, Week 12
Mean Change From Baseline in WOMAC C (Physical Function) Dimension Total Score
The Western Ontario and McMaster Universities developed the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score to use among patients with knee and/or hip OA. The WOMAC is a validated, multidimensional measure of pain, stiffness, and physical functional disability that is sensitive to the effects of drugs or other interventions. This study used the 11-box NPRS format ranging from 0 (none or no pain/stiffness/difficulty) to 10 (extreme).
The WOMAC is a self-administered index that contains 24 items asked in relation to the index knee joint. The WOMAC has 3 dimensions: Pain (Subscale A), Stiffness (Subscale B), and Physical Function (Subscale C). Lower scores mean a better outcome and higher scores mean a worse outcome.
The function dimension asks about the degree of difficulty in doing 17 activities due to the reference joint. The score ranges from 0 to 170.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start24 Jan 2018
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 332 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
- NCT03429049
- Sponsor's protocol ID
- CNTX-4975i-OA-301
- Status last verified
- Jul 2022
- First submitted
- 31 Jan 2018
- Last updated
- 26 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Injection, 52-Week Study to Evaluate the Efficacy and Safety of an Intra-articular Injection of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain
- ClinicalTrials.gov ID
- NCT03429049
- Acronym / sponsor ID
- CNTX-4975i-OA-301
- Conditions
- Osteoarthritis, Knee
- Keywords
- analgesic, non-opioid, capsaicin, intra-articular, osteoarthritis, pain, knee pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Posted 8 Apr 2022
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 3, randomized, double-blind, placebo-controlled, single injection, 52-week study to evaluate the analgesic efficacy and safety of a single intra-articular (IA) CNTX-4975-05 (capsaicin), compared to IA placebo, in subjects with chronic, moderate-to-severe osteoarthritis (OA) knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo of 2.0 mL for IA injection |
| CNTX-4975-05 | Experimental | Drug: CNTX-4975-05Pre-filled glass syringes administered as a single 2.0 mL IA injection |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects between 40 and 95 years of age (inclusive) at the time of the Screening Visit with the ability to comply with answering the electronic diary using the study-provided tablet computers.
- Confirmation of osteoarthritis (OA) of the knee.
- Confirmation of OA of the index knee.
- Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.
- BMI ≤45 kg/m^2.
Key exclusion criteria (15 listed)
- Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months.
- Prior arthroscopic surgery of the index knee within 6 months of Screening.
- Any painful conditions of the index knee due to joint disease other than OA.
- Periarticular pain from any cause.
- Pain in the non-index knee that is >3 on a numeric pain rating scale (NPRS) (0-10) when walking or at rest.
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-4975-05Receiving CNTX-4975-05 injection | Drug | CNTX-4975-05 |
| PlaceboReceiving Placebo injection | Drug | Placebo |
Primary outcome
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
Time frame: Baseline, Week 12
Average daily OA pain in the index knee while walking was evaluated using a 0 to 10 Numerical Pain Rating Scale (NPRS) (0 = no pain and 10 = worst possible pain). 0 was the best score and 10 was the worst score. Subjects used an ePRO at bedtime (9:00 PM ± 3 hours) to record on a daily basis their average daily OA knee pain score with walking during the previous 24 hours.
3 secondary outcomes
Mean Change From Baseline in WOMAC A (Pain) Dimension Total Score
Time frame: Baseline, Week 12
Mean Change From Baseline WOMAC B (Stiffness) Dimension Total Score
Time frame: Baseline, Week 12
Mean Change From Baseline in WOMAC C (Physical Function) Dimension Total Score
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CNTX-4975-05 in people with Osteoarthritis, Knee, run by Centrexion Therapeutics at 33 sites 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 9 inclusion and 15 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee (time frame: Baseline, Week 12). 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 26 Jul 2022.