Knee OsteoarthritisPhase 3NCT03661996
An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA
A Phase 3 study testing CNTX-4975-05, Lidocaine without epinephrine and ElastoGel in people with Knee Osteoarthritis, run by Centrexion Therapeutics at 28 sites in United States.
Trial summary
An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX 4975-05 Intra-articular Injection in Subjects with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- CNTX-4975-05, Lidocaine without epinephrine and ElastoGel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 854 participants
- Where
- 28 sitesUnited States
- Study dates
- 18 Sep 2018to 22 Oct 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)
- Confirmation of osteoarthritis (OA) of the knee: radiography of both knees using standard standing films (scored by the investigator) or using the fixed flexion method, taken during the Screening Visit of CNTX-4975i-OA-301 or CNTX-4975i-OA-304.
- Confirmation of OA of the index knee: American College of Rheumatology (ACR) diagnostic criteria
- For subjects for monoarticular knee injection, the index knee must have moderate to severe pain at screening associated with OA, which must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.
- These subjects may have:
- unilateral or bilateral OA, with the index knee having moderate to severe pain, and the contralateral knee having none to mild pain, OR
Show all 10Show fewer
- unilateral or bilateral OA, with the index knee having moderate to severe pain and the other knee having had a PJR or TJR within 5 years of the Screening Visit. The knee with the PJR/TJR is not to be injected with CNTX-4975-05.
- For subjects for bilateral knee injection, the index knee must have moderate to severe pain at screening associated with OA, and greater pain in the index knee than in the contralateral knee. Their pain must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator. The index knee in these subjects is the one with the worst pain with walking. Where both knees have equal pain with walking, then the knee on the subject's dominant side will be designated the index knee.
- For qualifying knee pain with walking, subjects will use an NPRS (0-10; 0=no pain, 10=worst possible pain) to rate their knee pain with walking (both knees, except knees with PJR/TJR). The PJR/TJR pain should be rated using the NPRS scale, but will not be a qualifying pain score.
- Body mass index ≤45 kg/m^2.
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. Joint replacement of the contralateral knee is permitted for subjects who will not receive an injection in the contralateral (natural) knee.
- 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. Radicular or referred pain involving the index knee or from joint disease other than OA involving the index knee, such as, but not restricted to chondromalacia patellae, inflammatory disease, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, etc.
- Periarticular pain from any cause, including referred pain, bursitis, tendonitis, soft tissue tenderness, or subacute/acute pain from injury.
- Other chronic pain anywhere in the body that requires the use of chronic analgesic medications, including, but not limited to, local painful areas, myofascial pain syndromes, fibromyalgia, genetic, metabolic abnormalities, hematologic, or neuropathic pain.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
First Surgical Hospital
Bellaire, Texas, 77401
Hassman Research Institute
Berlin, New Jersey, 08009
Alabama Orthopaedic Center-Research
Birmingham, Alabama, 35209
Med Center Medical Clinic
Carmichael, California, 95608
Core Healthcare Group
Cerritos, California, 90703
Metroplex Clinical Research Center
Dallas, Texas, 75231
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Healthcare Research Network II, LLC
Flossmoor, Illinois, 60422
Healthcare Research Network
Hazelwood, Missouri, 63042
Hermann Drive Surgical Hospital
Houston, Texas, 77004
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, 64114
Office of Robert P. Kaplan, DO
Las Vegas, Nevada, 89119
Conquest Clinical Research
Maitland, Florida, 32751
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060
Tandem Clinical Research
Marrero, Louisiana, 70072
F&T Medical Research, Inc.
Miami, Florida, 33184
M&M Medical Center, Inc.
Miami, Florida, 33185
Charter Research
Mt. Dora, Florida, 32757
DelRicht Research
New Orleans, Louisiana, 70115
Affinity Health
Oak Brook, Illinois, 60523
Premier MED Family & Sports Medicine
Ocoee, Florida, 34761
Holland Center for Family Health
Peoria, Arizona, 85381
Ascension Research
Pinellas Park, Florida, 33781
Encompass Clinical Research
Spring Valley, California, 91978
Atlanta Orthopaedic Institute, LLC
Stockbridge, Georgia, 30281
M&M Clinical Trials Sunrise
Sunrise, Florida, 33351
Noble Clinical Research
Tucson, Arizona, 85704
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
About this study
Official title: An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX-4975-05 Intra-articular Injection in Subjects With Chronic, Moderate-to-Severe Osteoarthritis Knee Pain
An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX 4975-05 Intra-articular Injection in Subjects with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain.
Read the detailed description
This is an open-label, single injection (per knee), 8-week study to evaluate the comfort and ease of use of 5 different treatment regimens, and to evaluate the efficacy and safety of a single intra-articular (IA) injection, in one or both knees, of CNTX-4975-05 in subjects with chronic, moderate-to-severe knee OA pain. Procedural pain associated with IA injection of the investigational product, CNTX-4975-05, will be controlled primarily through adjunct controlled joint cooling and secondarily by pre-medication with IA lidocaine.
- Conditions
- Knee Osteoarthritis
- Being tested
- CNTX-4975-05, Lidocaine without epinephrine, ElastoGel, Breg Ice Water Pump
- Keywords
- osteoarthritis, knee pain, non opioid, analgesic, capsaicin, pain, intra-articular
- 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
Also called capsaicin
Osteoarthritis (OA) intra-articular injection of CNTX-4975-05
Lidocaine without epinephrineDrug
Also called Lidocaine
15 mL lidocaine intra-articular injection
ElastoGelDevice
Cooling Device
Breg Ice Water PumpDevice
Cooling Device
| Study group | Role | What they receive |
|---|---|---|
| Breg Cooling Control Group | Experimental | Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Breg ice water pump. Receives: Drug: CNTX-4975-05; Drug: Lidocaine without epinephrine; Device: Breg Ice Water Pump |
| Gel Pack Cooling Group | Experimental | Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel. Receives: Drug: CNTX-4975-05; Drug: Lidocaine without epinephrine; Device: ElastoGel |
| Shortened Gel Pack Cooling Group | Experimental | Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel. Receives: Drug: CNTX-4975-05; Drug: Lidocaine without epinephrine; Device: ElastoGel |
| Single Needle Injection Gel Pack Cooling Group - 2% Lidocaine | Experimental | Subject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel. Receives: Drug: CNTX-4975-05; Drug: Lidocaine without epinephrine; Device: ElastoGel |
| Single Needle Injection Gel Pack Cooling Group - 1% Lidocaine | Experimental | Subject receives 1% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel. Receives: Drug: CNTX-4975-05; Drug: Lidocaine without epinephrine; Device: ElastoGel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Optimal Procedure for Administering CNTX-4975-05 With Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction
A composite score was calculated for each of the 5 treatment regimens by summing the scores of three assessments: (1) procedure pain 30 minutes after injection of CNTX-4975-05 on a 0-4 scale, 0 was best indicating no procedure pain, 4 was worst indicating severe procedure pain; (2) assessment of subjects' satisfaction with the regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied), 1 was worst and 7 was best; and (3) assessment of investigators' satisfaction with the regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied), 1 was worst and 7 was best.
The procedure pain at 30 minutes was reversed to a 1-7 scale so 7 was best indicating no procedure pain and 1 was worst indicating severe procedure pain. The three assessments were summed for a total score from 3-21, 3 being the worst outcome and 21 being the best outcome. The geometric mean of the scores was derived for each group.
All assessments were administered on Day 1 (Baseline).
Measured: Day 1 assessments
Secondary outcomes (7)
Mean Change From Baseline in KOOS "Symptoms" Subscale Score by Subject Type
The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related Quality of Life. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
The KOOS was administered on Day 1 (Baseline) and Week 8.
Higher scores (or positive change from baseline) indicate improvement.
Measured: Baseline, Week 8
Mean Change From Baseline in KOOS "Pain" Subscale Score by Subject Type
The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related Quality of Life. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
The KOOS was administered on Day 1 (Baseline) and Week 8.
Higher scores (or positive change from baseline) indicate improvement.
Measured: Baseline, Week 8
Mean Change From Baseline in KOOS "Pain With Walking" Single Question Score by Subject Type
The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related Quality of Life. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The KOOS Pain with Walking is a single question from the KOOS Pain subscale.
The KOOS was administered on Day 1 (Baseline) and Week 8.
Higher scores (or positive change from baseline) indicate improvement.
Measured: Baseline, Week 8
Mean Change From Baseline in KOOS "Function (Daily Living)" Subscale Score by Subject Type
The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
The KOOS was administered on Day 1 (Baseline) and Week 8.
Higher scores (or positive change from baseline) indicate improvement.
Measured: Baseline, Week 8
Mean Change From Baseline in KOOS "Function (Sport and Recreational Activities)" Subscale Score by Subject Type
The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
The KOOS was administered on Day 1 (Baseline) and Week 8.
Higher scores (or positive change from baseline) indicate improvement.
Measured: Baseline, Week 8
Mean Change From Baseline in KOOS "Knee-Related Quality of Life" Subscale Score by Subject Type
The KOOS (KOOS = Knee Injury and Osteoarthritis Outcome Score) was developed as an extension of the WOMAC (Western Ontario and McMaster Universities Arthritis Index) to evaluate the dimensions of knee osteoarthritis associated pain and injury. It includes 5 separately scored subscales: Pain, Symptoms (including stiffness), Function (Daily Living), Function (Sports and Recreational Activities), and knee-related QOL. Each subscale score is rated on a 5-point scale (i.e., 0 to 4). The previous week is the time period evaluated when answering the questions. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
The KOOS was administered on Day 1 (Baseline) and Week 8.
Higher scores (or positive change from baseline) indicate improvement.
Measured: Baseline, Week 8
Mean Change From Baseline in Average Daily Pain With Walking NPRS (0-10) Score by Subject Type
The pain with walking Numerical Pain Rating Scale (NPRS) (0-10, 0 being no pain, 10 being greatest pain) collected subjects' average pain with walking over the past 24 hours. Subjects recorded the pain in their target knee, either the index knee or additionally the non-index knee in the case of bilateral subjects. The NPRS was collected at Day 1 (Baseline) and Week 8.
Lower scores (or negative change from baseline) indicate improvement
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start18 Sep 2018
- Primary completion22 Oct 2019
- Study completion22 Oct 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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 854 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 Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661996
- Sponsor's protocol ID
- CNTX-4975i-OA-303
- Status last verified
- Jan 2022
- First submitted
- 28 Aug 2018
- Last updated
- 9 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX-4975-05 Intra-articular Injection in Subjects With Chronic, Moderate-to-Severe Osteoarthritis Knee Pain
- ClinicalTrials.gov ID
- NCT03661996
- Acronym / sponsor ID
- CNTX-4975i-OA-303
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis, knee pain, non opioid, analgesic, capsaicin, pain, intra-articular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 854 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 9 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different Treatment Regimens for CNTX 4975-05 Intra-articular Injection in Subjects with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain.
Detailed description
This is an open-label, single injection (per knee), 8-week study to evaluate the comfort and ease of use of 5 different treatment regimens, and to evaluate the efficacy and safety of a single intra-articular (IA) injection, in one or both knees, of CNTX-4975-05 in subjects with chronic, moderate-to-severe knee OA pain. Procedural pain associated with IA injection of the investigational product, CNTX-4975-05, will be controlled primarily through adjunct controlled joint cooling and secondarily by pre-medication with IA lidocaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Breg Cooling Control Group | Experimental | Drug: CNTX-4975-05, Drug: Lidocaine without epinephrine, Device: Breg Ice Water PumpSubject receives 2% lidocaine and CNTX-4975-05 with cooling device Breg ice water pump. |
| Gel Pack Cooling Group | Experimental | Drug: CNTX-4975-05, Drug: Lidocaine without epinephrine, Device: ElastoGelSubject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel. |
| Shortened Gel Pack Cooling Group | Experimental | Drug: CNTX-4975-05, Drug: Lidocaine without epinephrine, Device: ElastoGelSubject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel. |
| Single Needle Injection Gel Pack Cooling Group - 2% Lidocaine | Experimental | Drug: CNTX-4975-05, Drug: Lidocaine without epinephrine, Device: ElastoGelSubject receives 2% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel. |
| Single Needle Injection Gel Pack Cooling Group - 1% Lidocaine | Experimental | Drug: CNTX-4975-05, Drug: Lidocaine without epinephrine, Device: ElastoGelSubject receives 1% lidocaine and CNTX-4975-05 with cooling device Elasto-Gel. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subjects between 40 and 95 years of age (inclusive)
- Confirmation of osteoarthritis (OA) of the knee: radiography of both knees using standard standing films (scored by the investigator) or using the fixed flexion method, taken during the Screening Visit of CNTX-4975i-OA-301 or CNTX-4975i-OA-304.
- Confirmation of OA of the index knee: American College of Rheumatology (ACR) diagnostic criteria
- For subjects for monoarticular knee injection, the index knee must have moderate to severe pain at screening associated with OA, which must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.
- unilateral or bilateral OA, with the index knee having moderate to severe pain, and the contralateral knee having none to mild pain, OR
Key exclusion criteria (5 listed)
- Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months. Joint replacement of the contralateral knee is permitted for subjects who will not receive an injection in the contralateral (natural) knee.
- 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. Radicular or referred pain involving the index knee or from joint disease other than OA involving the index knee, such as, but not restricted to chondromalacia patellae, inflammatory disease, metabolic diseases, gout/pseudogout, hemochromatosis, acromegaly, etc.
- Periarticular pain from any cause, including referred pain, bursitis, tendonitis, soft tissue tenderness, or subacute/acute pain from injury.
- Other chronic pain anywhere in the body that requires the use of chronic analgesic medications, including, but not limited to, local painful areas, myofascial pain syndromes, fibromyalgia, genetic, metabolic abnormalities, hematologic, or neuropathic pain.
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: capsaicinOsteoarthritis (OA) intra-articular injection of CNTX-4975-05 | Drug | Breg Cooling Control Group, Gel Pack Cooling Group, Shortened Gel Pack Cooling Group, Single Needle Injection Gel Pack Cooling Group - 1% Lidocaine, Single Needle Injection Gel Pack Cooling Group - 2% Lidocaine |
| Lidocaine without epinephrineAlso: Lidocaine15 mL lidocaine intra-articular injection | Drug | Breg Cooling Control Group, Gel Pack Cooling Group, Shortened Gel Pack Cooling Group, Single Needle Injection Gel Pack Cooling Group - 1% Lidocaine, Single Needle Injection Gel Pack Cooling Group - 2% Lidocaine |
| ElastoGelCooling Device | Device | Gel Pack Cooling Group, Shortened Gel Pack Cooling Group, Single Needle Injection Gel Pack Cooling Group - 1% Lidocaine, Single Needle Injection Gel Pack Cooling Group - 2% Lidocaine |
| Breg Ice Water PumpCooling Device | Device | Breg Cooling Control Group |
Primary outcome
Determination of Optimal Procedure for Administering CNTX-4975-05 With Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction
Time frame: Day 1 assessments
A composite score was calculated for each of the 5 treatment regimens by summing the scores of three assessments: (1) procedure pain 30 minutes after injection of CNTX-4975-05 on a 0-4 scale, 0 was best indicating no procedure pain, 4 was worst indicating severe procedure pain; (2) assessment of subjects' satisfaction with the regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied), 1 was worst and 7 was best; and (3) assessment of investigators' satisfaction with the regimen on a scale of 1 (completely dissatisfied) to 7 (completely satisfied), 1 was worst and 7 was best. The procedure pain at 30 minutes was reversed to a 1-7 scale so 7 was best indicating no procedure pain and 1 was worst indicating severe procedure pain. The three assessments were summed for a total score from 3-21, 3 being the worst outcome and 21 being the best outcome. The geometric mean of the scores was derived for each group. All assessments were administered on Day 1 (Baseline).
7 secondary outcomes
Mean Change From Baseline in KOOS "Symptoms" Subscale Score by Subject Type
Time frame: Baseline, Week 8
Mean Change From Baseline in KOOS "Pain" Subscale Score by Subject Type
Time frame: Baseline, Week 8
Mean Change From Baseline in KOOS "Pain With Walking" Single Question Score by Subject Type
Time frame: Baseline, Week 8
Mean Change From Baseline in KOOS "Function (Daily Living)" Subscale Score by Subject Type
Time frame: Baseline, Week 8
Mean Change From Baseline in KOOS "Function (Sport and Recreational Activities)" Subscale Score by Subject Type
Time frame: Baseline, Week 8
Mean Change From Baseline in KOOS "Knee-Related Quality of Life" Subscale Score by Subject Type
Time frame: Baseline, Week 8
Mean Change From Baseline in Average Daily Pain With Walking NPRS (0-10) Score by Subject Type
Time frame: Baseline, Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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 Corp
28 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, Lidocaine without epinephrine and ElastoGel in people with Knee Osteoarthritis, run by Centrexion Therapeutics at 28 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 10 inclusion and 5 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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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. 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 9 Mar 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?
Determination of Optimal Procedure for Administering CNTX-4975-05 With Regards to Pain, Participant Satisfaction, and Investigator's Satisfaction (time frame: Day 1 assessments). 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 9 Mar 2022.