Osteoarthritis, KneePhase 3NCT03660943
A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain
A Phase 3 study testing CNTX-4975-05 in people with Osteoarthritis, Knee, run by Centrexion Therapeutics at 30 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, 2-injection, 52-week study to evaluate the efficacy and safety of intra-articular injections of CNTX-4975-05 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
- 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
- 30 sitesUnited States
- Study dates
- 9 Sep 2018to 11 Jun 2020
- 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 the 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.
- Body Mass Index (BMI) ≤45 kg/m^2
- Must have failed 2 or more prior therapies.
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 the OA.
- Periarticular pain from any cause.
- Other chronic pain anywhere in the body that requires the use of analgesic medications.
- Instability of the index knee.
Show all 14Show fewer
- 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
30 sites in 1 country.
30 sites in 1 country
United States30 sites
First Surgical Hospital
Bellaire, Texas, 77401
Med Center Medical Clinic
Carmichael, California, 95608
Spectrum Medical, Inc.
Danville, Virginia, 24541
TriWest Research Associates
El Cajon, California, 92020
Lillestol Research LLC
Fargo, North Dakota, 58104
Healthcare Research Network, LLC
Flossmoor, Illinois, 60422
Holland Center for Family Health
Glendale, Arizona, 85306
Drug Trials America
Hartsdale, New York, 10530
Healthcare Research Network
Hazelwood, Missouri, 63042
Office of Robert P. Kaplan, DO
Las Vegas, Nevada, 89119
Panamerican Health Center, Inc.
Miami, Florida, 33126
Well Pharma Medical Research, Corp
Miami, Florida, 33143
Quality Research & Medical Center LLC
Miami, Florida, 33186
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, 33014
BTC of New Bedford, LLC
New Bedford, Massachusetts, 02740
DelRicht Research
New Orleans, Louisiana, 70115
Heartland Medical, PC
New Tazewell, Tennessee, 37825
Better Health Clinical Research, Inc.
Newnan, Georgia, 30265
Coastal Carolina Research Center at Arcis Healthcare, LLC dba Lowcountry Orthopaedics & Sports Medicine
North Charleston, South Carolina, 29406
Affinity Clinical Research Institute
Oak Brook, Illinois, 60523
Journey Research, Inc.
Oldsmar, Florida, 34677
GB Family Care
Phoenix, Arizona, 85037
Arizona Research Center
Phoenix, Arizona, 85053
Arthritis Care and Research Center, Inc. (ACRC Studies)
Poway, California, 92064
Clinical Trials of Texas, Inc
San Antonio, Texas, 78229
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258
M&M Clinical Trials Sunrise
Sunrise, Florida, 33351
Chase Medical Research, LLC
Waterbury, Connecticut, 06708
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
Conquest Research
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, 2-Injection, 52-Week Study to Evaluate the Efficacy and Safety of Intra-articular Injections of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain
This is a randomized, double-blind, placebo-controlled, 2-injection, 52-week study to evaluate the efficacy and safety of intra-articular injections of CNTX-4975-05 in subjects with chronic, moderate-to-severe osteoarthritis knee pain.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Placebo, CNTX-4975-05
- 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.
PlaceboDrug
Receiving Placebo Injection
CNTX-4975-05Drug
Receiving CNTX-4975-05 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.
Mean Change From Baseline in WOMAC A (Pain) Dimension
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
Secondary outcomes (3)
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
Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension
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 Study Baseline in WOMAC C (Function) Dimension
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, Week12
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 start9 Sep 2018
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
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 Stevens, MD, Study chair, Centrexion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660943
- Sponsor's protocol ID
- CNTX-4975i-OA-304
- Status last verified
- Jul 2022
- First submitted
- 27 Aug 2018
- Last updated
- 21 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 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, 2-Injection, 52-Week Study to Evaluate the Efficacy and Safety of Intra-articular Injections of CNTX-4975-05 in Subjects With Chronic, Moderate-to-severe Osteoarthritis Knee Pain
- ClinicalTrials.gov ID
- NCT03660943
- Acronym / sponsor ID
- CNTX-4975i-OA-304
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Centrexion TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2018 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Posted 21 Jul 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 randomized, double-blind, placebo-controlled, 2-injection, 52-week study to evaluate the efficacy and safety of intra-articular injections of CNTX-4975-05 in subjects with chronic, moderate-to-severe osteoarthritis 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 (6 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 the 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.
- Body Mass Index (BMI) ≤45 kg/m^2
Key exclusion criteria (14 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 the OA.
- Periarticular pain from any cause.
- Other chronic pain anywhere in the body that requires the use of analgesic medications.
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 |
|---|---|---|
| PlaceboReceiving Placebo Injection | Drug | Placebo |
| CNTX-4975-05Receiving CNTX-4975-05 Injection | Drug | CNTX-4975-05 |
Primary outcome
Mean Change From Baseline in WOMAC A (Pain) Dimension
Time frame: Baseline, Week 12
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.
3 secondary outcomes
Change From Baseline in Average Weekly Pain With Walking (NPRS 0-10) in the Index Knee
Time frame: Baseline, Week 12
Mean Change From Study Baseline in WOMAC B (Stiffness) Dimension
Time frame: Baseline, Week 12
Mean Change From Study Baseline in WOMAC C (Function) Dimension
Time frame: Baseline, Week12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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 Stevens, MD study chair
Centrexion Therapeutics
30 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 30 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 6 inclusion and 14 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 21 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 30 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 21 Jul 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?
Mean Change From Baseline in WOMAC A (Pain) Dimension (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 21 Jul 2022.